Saturday, October 19, 2019

Saturday, October 19, 2019

FDA OK'd 438 drugs in April


The U.S. Food and Drug Administration approved 438 drug products in April, according to an online list the agency updated this week.

The list includes original and supplemental approvals for new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs), the FDA said. Supplemental approvals might have been granted in the first week of April.

The FDA defines biologics as natural materials such as enzymes, antibodies or hormones in the human body.

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FDA Drug Approvals in April

Approval DateDrug NameSubmissionCompanySubmission ClassificationSubmission Status
April 1DOCETAXEL ANDA #204193SUPPL-6DR REDDYS LABS LTDLabelingApproval
April 1DOCETAXEL ANDA #208137ORIG-1MYLAN LABS LTD

Approval
April 1MIRABEGRON ANDA #209488ORIG-1ZYDUS PHARMS USA INC

Tentative Approval
April 1PANTOPRAZOLE SODIUM ANDA #209524ORIG-1HANGZHOU ZHONGMEI HUADONG

Tentative Approval
April 1LEVOCETIRIZINE HYDROCHLORIDE ANDA #210914ORIG-1HETERO LABS LTD III

Approval
April 2VYTORIN NDA #021687SUPPL-52MSD INTLLabelingApproval
April 2XYZAL NDA #022064SUPPL-38SANOFI AVENTIS USLabelingApproval
April 2XYZAL NDA #022157SUPPL-20SANOFI AVENTIS USLabelingApproval
April 2ADDYI NDA #022526SUPPL-7SPROUT PHARMSREMSApproval
April 2BENAZEPRIL HYDROCHLORIDE ANDA #076430SUPPL-12MYLANLabelingApproval
April 2BENAZEPRIL HYDROCHLORIDE ANDA #077128SUPPL-15APOTEX INCLabelingApproval
April 2BENAZEPRIL HYDROCHLORIDE ANDA #078212SUPPL-17AUROBINDO PHARMALabelingApproval
April 2EPLERENONE ANDA #078510SUPPL-13SANDOZLabelingApproval
April 2EPLERENONE ANDA #078510SUPPL-14SANDOZLabelingApproval
April 2CELECOXIB ANDA #078857SUPPL-5MYLANLabelingApproval
April 2AZELASTINE HYDROCHLORIDE ANDA #090423SUPPL-19SUN PHARMLabelingApproval
April 2SILDENAFIL CITRATE ANDA #091479SUPPL-10TORRENT PHARMS LTDLabelingApproval
April 2SILDENAFIL CITRATE ANDA #091479SUPPL-11TORRENT PHARMS LTDLabelingApproval
April 2SILDENAFIL CITRATE ANDA #201150SUPPL-3MYLAN PHARMS INCLabelingApproval
April 2SILDENAFIL CITRATE ANDA #201150SUPPL-6MYLAN PHARMS INCLabelingApproval
April 2SILDENAFIL CITRATE ANDA #201150SUPPL-7MYLAN PHARMS INCLabelingApproval
April 2SILDENAFIL CITRATE ANDA #201150SUPPL-9MYLAN PHARMS INCLabelingApproval
April 2LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653SUPPL-4SUN PHARM INDS LTDLabelingApproval
April 2LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653SUPPL-5SUN PHARM INDS LTDLabelingApproval
April 2LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #201653SUPPL-6SUN PHARM INDS LTDLabelingApproval
April 2EZETIMIBE AND SIMVASTATIN ANDA #201890SUPPL-5ANI PHARMS INCLabelingApproval
April 2CARISOPRODOL ANDA #203374SUPPL-12SCIEGEN PHARMS INCLabelingApproval
April 2SILDENAFIL CITRATE ANDA #203623SUPPL-1HETERO LABS LTD VLabelingApproval
April 2SILDENAFIL CITRATE ANDA #203623SUPPL-3HETERO LABS LTD VLabelingApproval
April 2LINEZOLID ANDA #204239SUPPL-1HETERO LABS LTD VLabelingApproval
April 2LINEZOLID ANDA #204239SUPPL-2HETERO LABS LTD VLabelingApproval
April 2TELMISARTAN ANDA #206511SUPPL-3AUROBINDO

PHARMA LTD

LabelingApproval
April 2SELEGILINE HYDROCHLORIDE ANDA #206803ORIG-1PACK PHARMS LLC

Approval
April 2FINGOLIMOD ANDA #207939ORIG-1HEC PHARM

Tentative Approval
April 2ASPIRIN AND DIPYRIDAMOLE ANDA #208572SUPPL-1SUN PHARMLabelingApproval
April 2CELECOXIB ANDA #208833SUPPL-1AMNEAL PHARMSLabelingApproval
April 2BUPIVACAINE HYDROCHLORIDE ANDA #209087ORIG-1B BRAUN MEDICAL INC

Approval
April 2CARMUSTINE ANDA #209278ORIG-1STI PHARMA LLC

Approval
April 2BETAMETHASONE DIPROPIONATE ANDA #211540ORIG-1PERRIGO UK FINCO

Tentative Approval
April 3LOTRONEX NDA #021107SUPPL-29SEBELA IRELAND LTDLabelingApproval
April 3LOVAZA NDA #021654SUPPL-43SMITHKLINE BEECHAMLabelingApproval
April 3BRILINTA NDA #022433SUPPL-23ASTRAZENECA PHARMSEfficacyApproval
April 3CLOPIDOGREL BISULFATE ANDA #090540SUPPL-12AUROBINDO PHARMA LTDLabelingApproval
April 3CLOPIDOGREL BISULFATE ANDA #090540SUPPL-13AUROBINDO PHARMA LTDLabelingApproval
April 3CLOPIDOGREL BISULFATE ANDA #090540SUPPL-14AUROBINDO PHARMA LTDLabelingApproval
April 3CLOPIDOGREL BISULFATE ANDA #090540SUPPL-15AUROBINDO PHARMA LTDLabelingApproval
April 3CLOPIDOGREL BISULFATE ANDA #090540SUPPL-17AUROBINDO PHARMA LTDLabelingApproval
April 3AMPICILLIN SODIUM ANDA #090889SUPPL-1ACS DOBFAR SPALabelingApproval
April 3AMPICILLIN SODIUM ANDA #090889SUPPL-2ACS DOBFAR SPALabelingApproval
April 3AVASTIN BLA #125085SUPPL-329GENENTECH

Approval
April 3EPLERENONE ANDA #206922SUPPL-1ACCORD HLTHCARELabelingApproval
April 3ROSUVASTATIN CALCIUM ANDA #207408SUPPL-2CHANGZHOU PHARMLabelingApproval
April 3ROSUVASTATIN CALCIUM ANDA #207408SUPPL-8CHANGZHOU PHARMLabelingApproval
April 3ESTRADIOL AND NORETHINDRONE ACETATE ANDA #210612ORIG-1NOVAST LABS

Approval
April 3WELCHOL NDA #210895ORIG-1DAIICHI SANKYO

INC

Type 3 - New Dosage FormApproval
April 3PERMETHRIN ANDA #211303ORIG-1ENCUBE ETHICALS

Approval
April 3FLUOCINONIDE ANDA #211758ORIG-1TELIGENT PHARMA INC

Approval
April 4SOMA NDA #011792SUPPL-50MYLAN SPECIALITY LPLabelingApproval
April 4ZANTAC 75 NDA #020520SUPPL-37SANOFI USLabelingApproval
April 4PRILOSEC OTC NDA #021229SUPPL-33ASTRAZENECA PHARMSLabelingApproval
April 4ZANTAC 150 NDA #021698SUPPL-29SANOFI USLabelingApproval
April 4MOMETASONE FUROATE ANDA #075919SUPPL-6FOUGERA PHARMSLabelingApproval
April 4LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #091629SUPPL-19AUROBINDO PHARMAManufacturing (CMC)Approval
April 4BICALUTAMIDE ANDA #200274SUPPL-1APOTEX INCLabelingApproval
April 4BICALUTAMIDE ANDA #200274SUPPL-2APOTEX INCLabelingApproval
April 4BUSULFAN ANDA #202259SUPPL-2LUITPOLDLabelingApproval
April 4BUSULFAN ANDA #202259SUPPL-4LUITPOLDLabelingApproval
April 4BUSULFAN ANDA #202259SUPPL-6LUITPOLDLabelingApproval
April 4TELMISARTAN AND AMLODIPINE ANDA #202517SUPPL-4TORRENTLabelingApproval
April 4TELMISARTAN AND AMLODIPINE ANDA #202517SUPPL-7TORRENTLabelingApproval
April 4LOSARTAN POTASSIUM ANDA #203835SUPPL-4HETERO LABS LTD VLabelingApproval
April 4RIVASTIGMINE TARTRATE ANDA #204572SUPPL-2AUROBINDO PHARMA LTDLabelingApproval
April 4RIVASTIGMINE TARTRATE ANDA #204572SUPPL-5AUROBINDO PHARMA LTDLabelingApproval
April 4NEXIUM 24HR NDA #204655SUPPL-11ASTRAZENECA LPLabelingApproval
April 4LOSARTAN POTASSIUM ANDA #204795ORIG-1HISUN PHARM HANGZHOU

Approval
April 4BUSULFAN ANDA #205106SUPPL-1ATHENEX INCLabelingApproval
April 4BUSULFAN ANDA #205139SUPPL-2ACTAVIS LLCLabelingApproval
April 4BUSULFAN ANDA #205139SUPPL-3ACTAVIS LLCLabelingApproval
April 4TIGECYCLINE NDA #205645SUPPL-3FRESENIUS KABI USALabelingApproval
April 4PITAVASTATIN CALCIUM ANDA #206070ORIG-1MYLAN PHARMS INC

Approval
April 4ENTECAVIR ANDA #206745SUPPL-1ZYDUS PHARMSLabelingApproval
April 4ENTECAVIR ANDA #206745SUPPL-3ZYDUS PHARMSLabelingApproval
April 4ENTECAVIR ANDA #206745SUPPL-4ZYDUS PHARMSLabelingApproval
April 4IBRANCE NDA #207103SUPPL-8PFIZER INCEfficacyApproval
April 4NEXIUM 24HR NDA #207920SUPPL-5ASTRAZENECA LPLabelingApproval
April 4HALOPERIDOL DECANOATE ANDA #209101SUPPL-1SOMERSET THERAPS LLCLabelingApproval
April 4HALOPERIDOL DECANOATE ANDA #209101SUPPL-2SOMERSET THERAPS LLCLabelingApproval
April 4PLENVU NDA #209381SUPPL-1SALIXLabelingApproval
April 4OLOPATADINE HYDROCHLORIDE ANDA #209995ORIG-1AUROBINDO PHARMA LTD

Approval
April 4TREMFYA BLA #761061SUPPL-2JANSSEN BIOTECH

Approval
April 5RAPAMUNE NDA #021083SUPPL-65PF PRISM CVLabelingApproval
April 5 RAPAMUNE NDA #021110SUPPL-84PF PRISM CVLabelingApproval
April 5SERTRALINE HYDROCHLORIDE ANDA #076934SUPPL-7ACI HEALTHCARE LTDLabelingApproval
April 5METOCLOPRAMIDE HYDROCHLORIDE ANDA #078807SUPPL-10IPCA LABS LTDLabelingApproval
April 5ARIPIPRAZOLE ANDA #201519SUPPL-33TORRENTLabelingApproval
April 5ARIPIPRAZOLE ANDA #201519SUPPL-35TORRENTLabelingApproval
April 5ARIPIPRAZOLE ANDA #201519SUPPL-36TORRENTLabelingApproval
April 5DIFICID NDA #201699SUPPL-11CUBIST PHARMS LLCLabelingApproval
April 5KETOROLAC TROMETHAMINE ANDA #203410ORIG-1MICRO LABS LTD INDIA

Approval
April 5LACOSAMIDE ANDA #204947ORIG-1ZYDUS PHARMS USA INC

Tentative Approval
April 5TOFACITINIB CITRATE ANDA #209829ORIG-1ZYDUS PHARMS USA INC

Tentative Approval
April 5Bortezomib ANDA #210615ORIG-1SHILPA MEDICARE LTD

Tentative Approval
April 5THIOTHIXENE ANDA #211642ORIG-1NOVITIUM PHARMA

Approval
April 5RANITIDINE HYDROCHLORIDE ANDA #211893ORIG-1APPCO PHARMA LLC

Approval
April 8ULTRAM NDA #020281SUPPL-41JANSSEN PHARMSLabelingApproval
April 8SOLTAMOX NDA #021807SUPPL-6MIDATECH PHARMA USLabelingApproval
April 8OMEPRAZOLE NDA #022032SUPPL-41DEXCEL PHARMALabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-5SUN PHARMLabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-6SUN PHARMLabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-7SUN PHARMLabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-8SUN PHARMLabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-9SUN PHARMLabelingApproval
April 8IMATINIB MESYLATE ANDA #078340SUPPL-12SUN PHARMLabelingApproval
April 8MENEST ANDA #084948SUPPL-23MONARCH PHARMSLabelingApproval
April 8MENEST ANDA #084949SUPPL-23MONARCH PHARMSLabelingApproval
April 8MENEST ANDA #084950SUPPL-20MONARCH PHARMSLabelingApproval
April 8MENEST ANDA #084951SUPPL-24MONARCH PHARMSLabelingApproval
April 8TETRABENAZINE ANDA #209739ORIG-1WEST-WARD PHARMS INT

Approval
April 8ICATIBANT ANDA #210118ORIG-1TEVA PHARMS USA INC

Tentative Approval
April 8CLOMIPRAMINE HYDROCHLORIDE ANDA #211767ORIG-1MANKIND PHARMA

Approval
April 8DOLUTEGRAVIR; LAMIVUDINE NDA #211994ORIG-1VIIV HLTHCAREType 4 - New CombinationApproval
April 9PAMELOR NDA #018013SUPPL-64SPECGX LLCLabelingApproval
April 9 PEPCID AC NDA #020325SUPPL-33J AND J CONSUMER INCLabelingApproval
April 9AXID AR NDA #020555SUPPL-10PFIZERLabelingApproval
April 9VAGIFEM NDA #020908SUPPL-26NOVO NORDISK INCLabelingApproval
April 9PEPCID COMPLETE NDA #020958SUPPL-28J AND J CONSUMER INCLabelingApproval
April 9PREVACID 24 HR NDA #022327SUPPL-27GLAXOSMITHKLINE CONSLabelingApproval
April 9ROSUVASTATIN CALCIUM ANDA #207626ORIG-1UMEDICA LABS PVT LTD

Approval
April 9LANSOPRAZOLE NDA #208025SUPPL-8DEXCEL PHARMALabelingApproval
April 9HYDROXYPROGESTERONE CAPROATE ANDA #208381ORIG-1SUN PHARM

Approval
April 9DECITABINE ANDA #209056ORIG-1WOCKHARDT BIO AG

Approval
April 9SEYSARA NDA #209521SUPPL-1ALMIRALLLabelingApproval
April 9OZEMPIC NDA #209637SUPPL-1NOVOLabelingApproval
April 9EVENITY BLA #761062ORIG-1AMGEN INC

Approval
April 10WELCHOL NDA #022362SUPPL-24DAIICHI SANKYOLabelingApproval
April 10TESTOSTERONE ANDA #204570ORIG-1ACTAVIS LABS UT INC

Approval
April 10ALEVE PM NDA #205352SUPPL-13BAYER HLTHCARELabelingApproval
April 10TESTOSTERONE ANDA #207373ORIG-1AMNEAL PHARMS LLC

Approval
April 10LURASIDONE HYDROCHLORIDE ANDA #208058ORIG-1EMCURE PHARMS LTD

Tentative Approval
April 10NAFTIFINE HYDROCHLORIDE ANDA #208201ORIG-1TARO

Approval
April 10AMBRISENTAN ANDA #208354ORIG-1SIGMAPHARM LABS LLC

Approval
April 10TESTOSTERONE ANDA #208560ORIG-1LUPIN ATLANTIS

Approval
April 10TESTOSTERONE ANDA #208620ORIG-1DR REDDYS LABS INC

Approval
April 10AMBRISENTAN ANDA #209509ORIG-1PAR PHARM INC

Approval
April 10ESOMEPRAZOLE MAGNESIUM ANDA #209647ORIG-1AMNEAL PHARMS NY

Approval
April 10SODIUM NITROPRUSSIDE ANDA #210114ORIG-1DR REDDYS LABS LTD

Approval
April 10TEMIXYS NDA #211284SUPPL-1CELLTRIONLabelingApproval
April 11DESOXYN NDA #005378SUPPL-35RECORDATI RARELabelingApproval
April 11SANDOSTATIN NDA #019667SUPPL-67NOVARTISLabelingApproval
April 11NAPHCON-A NDA #020226SUPPL-29ALCONLabelingApproval
April 11MIFEPREX NDA #020687SUPPL-22DANCO LABS LLCREMSApproval
April 11SANDOSTATIN LAR NDA #021008SUPPL-43NOVARTISLabelingApproval
April 11SOMATULINE DEPOT NDA #022074SUPPL-24IPSEN PHARMALabelingApproval
April 11ZYPREXA RELPREVV NDA #022173SUPPL-32ELI LILLY COREMSApproval
April 11ADDYI NDA #022526SUPPL-6SPROUT PHARMSSupplementApproval
April 11CLOPIDOGREL BISULFATE ANDA #077665SUPPL-7MYLAN PHARMS INCLabelingApproval
April 11MIFEPRISTONE ANDA #091178ORIG-1GENBIOPRO

Approval
April 11ACTEMRA BLA #125276SUPPL-120GENENTECH

Approval
April 11ACTEMRA BLA #125276SUPPL-121GENENTECH

Approval
April 11ACTEMRA BLA #125472SUPPL-37GENENTECH

Approval
April 11KEYTRUDA BLA #125514SUPPL-47MERCK SHARP DOHME

Approval
April 11REPATHA BLA #125522SUPPL-20AMGEN INC

Approval
April 11SIGNIFOR NDA #200677SUPPL-5NOVARTISLabelingApproval
April 11SIGNIFOR LAR KIT NDA #203255SUPPL-7NOVARTIS PHARMS CORPLabelingApproval
April 11EPLERENONE ANDA #203896SUPPL-2MYLANLabelingApproval
April 11LEVOTHYROXINE SODIUM NDA #210632ORIG-1FRESENIUS KABI USAType 3 - New Dosage FormApproval
April 12BECONASE AQ NDA #019389SUPPL-34GLAXOSMITHKLINELabelingApproval
April 12LIPITOR NDA #020702SUPPL-73PFIZERLabelingApproval
April 12CYPROHEPTADINE HYDROCHLORIDE ANDA #206676ORIG-1BEXIMCO PHARMS USA

Approval
April 12DAUNORUBICIN HYDROCHLORIDE ANDA #208759ORIG-1HISUN PHARM HANGZHOU

Approval
April 12BIMATOPROST ANDA #210263ORIG-1ALEMBIC PHARMS LTD

Approval
April 12BALVERSA NDA #212018ORIG-1JANSSEN BIOTECHType 1 - New Molecular EntityApproval
April 15EXCEDRIN (MIGRAINE) NDA #020802SUPPL-33GLAXOSMITHKLINE CONSLabelingApproval
April 15 VERDESO NDA #021978SUPPL-15ALMIRALLLabelingApproval
April 15LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375SUPPL-9HIKMA FARMACEUTICALabelingApproval
April 15LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #091375SUPPL-12HIKMA FARMACEUTICALabelingApproval
April 15ACETAZOLAMIDE SODIUM ANDA #206533ORIG-1ZYDUS PHARMS

Approval
April 15DOXYCYCLINE HYCLATE ANDA #209243ORIG-1APOTEX INC

Approval
April 15CLOBAZAM ANDA #210978ORIG-1TARO PHARM

Approval
April 15FLUOXETINE HYDROCHLORIDE ANDA #211653ORIG-1LUPIN LTD

Approval
April 15TRANEXAMIC ACID IN SODIUM CHLORIDE INJECTION NDA #212020ORIG-1EXELA PHARMA SCIENCEType 5 - New Formulation or New ManufacturerApproval
April 16MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020488SUPPL-24HOSPIRALabelingApproval
April 16CIPROFLOXACIN ANDA #076717SUPPL-6HIKMA FARMACEUTICALabelingApproval
April 16RIVASTIGMINE TARTRATE ANDA #077131SUPPL-6SUN PHARMLabelingApproval
April 16RIVASTIGMINE TARTRATE ANDA #077131SUPPL-10SUN PHARMLabelingApproval
April 16LEVOFLOXACIN ANDA #077652SUPPL-8ZYDUS PHARMS USA INCLabelingApproval
April 16LEVOFLOXACIN ANDA #077652SUPPL-10ZYDUS PHARMS USA INCLabelingApproval
April 16LEVOFLOXACIN ANDA #077652SUPPL-14ZYDUS PHARMS USA INCLabelingApproval
April 16LEVOFLOXACIN ANDA #077652SUPPL-15ZYDUS PHARMS USA INCLabelingApproval
April 16SUMATRIPTAN SUCCINATE ANDA #077744SUPPL-8MYLANLabelingApproval
April 16CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252SUPPL-30INFORLIFELabelingApproval
April 16CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078252SUPPL-31INFORLIFELabelingApproval
April 16CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #078431SUPPL-9HIKMA FARMACEUTICALabelingApproval
April 16ROCURONIUM BROMIDE ANDA #078717SUPPL-23TEVA PHARMSLabelingApproval
April 16BICALUTAMIDE ANDA #079089SUPPL-4ZYDUS PHARMS USA INCLabelingApproval
April 16BICALUTAMIDE ANDA #079089SUPPL-5ZYDUS PHARMS USA INCLabelingApproval
April 16ROCURONIUM BROMIDE ANDA #079199SUPPL-9MYLAN INSTITUTIONALLabelingApproval
April 16ROCURONIUM BROMIDE ANDA #079199SUPPL-10MYLAN INSTITUTIONALLabelingApproval
April 16NEULASTA BLA #125031SUPPL-198AMGEN

Approval
April 16BUSPIRONE HYDROCHLORIDE ANDA #202087SUPPL-1YILING PHARM LTDLabelingApproval
April 16TELMISARTAN ANDA #202130SUPPL-8ALEMBIC PHARMS LTDLabelingApproval
April 16TELMISARTAN ANDA #203325SUPPL-3ZYDUS PHARMSLabelingApproval
April 16LEVOFLOXACIN ANDA #203613SUPPL-2JUBILANT GENERICSLabelingApproval
April 16LEVOFLOXACIN ANDA #203613SUPPL-3JUBILANT GENERICSLabelingApproval
April 16ROCURONIUM BROMIDE ANDA #204679SUPPL-4WEST WARD PHARM CORPLabelingApproval
April 16DESIPRAMINE HYDROCHLORIDE ANDA #205153SUPPL-1ANI PHARMS INCLabelingApproval
April 16RIVASTIGMINE ANDA #205622SUPPL-1MYLAN TECHNOLOGIESLabelingApproval
April 16ENTECAVIR ANDA #206652SUPPL-2AMNEAL PHARMSLabelingApproval
April 16ENTECAVIR ANDA #206652SUPPL-3AMNEAL PHARMSLabelingApproval
April 16ENTECAVIR ANDA #206652SUPPL-5AMNEAL PHARMSLabelingApproval
April 16ASPIRIN AND DIPYRIDAMOLE ANDA #206964SUPPL-7ANI PHARMS INCLabelingApproval
April 16DESIPRAMINE HYDROCHLORIDE ANDA #207433SUPPL-3HERITAGE PHARMS INCLabelingApproval
April 16DESIPRAMINE HYDROCHLORIDE ANDA #208105SUPPL-4AMNEAL PHARMS COLabelingApproval
April 16BUSPIRONE HYDROCHLORIDE ANDA #208972ORIG-1EPIC PHARMA LLC

Approval
April 16EZETIMIBE AND SIMVASTATIN ANDA

#209222

SUPPL-2ALKEM LABS LTDLabelingApproval
April 16ELCYS NDA #210660ORIG-1EXELA PHARMA SCS LLCType 5 - New Formulation or New ManufacturerApproval
April 16NIFEDIPINE ANDA #210838ORIG-1SPIL

Approval
April 16HYDROXYPROGESTERONE CAPROATE ANDA #211070ORIG-1EUGIA PHARMA

Approval
April 16HYDROXYPROGESTERONE CAPROATE ANDA #211071ORIG-1EUGIA PHARMA

Approval
April 16ACETAMINOPHEN ANDA #211544ORIG-1GRANULES INDIA LTD

Approval
April 16UDENYCA BLA #761039SUPPL-1COHERUS BIOSCIENCES INC

Approval
April 17LEVOFLOXACIN ANDA #078424SUPPL-13LUPINLabelingApproval
April 17LEVOFLOXACIN ANDA #078424SUPPL-14LUPINLabelingApproval
April 17LEVOFLOXACIN ANDA #078424SUPPL-16LUPINLabelingApproval
April 17LEVOFLOXACIN ANDA #078424SUPPL-17LUPINLabelingApproval
April 17LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343SUPPL-22INFORLIFELabelingApproval
April 17LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #090343SUPPL-24INFORLIFELabelingApproval
April 17LEVOFLOXACIN ANDA #090722SUPPL-10TORRENT PHARMSLabelingApproval
April 17LEVOFLOXACIN ANDA #090722SUPPL-11TORRENT PHARMSLabelingApproval
April 17LEVOFLOXACIN ANDA #090722SUPPL-12TORRENT PHARMSLabelingApproval
April 17LEVOFLOXACIN ANDA #090722SUPPL-13TORRENT PHARMSLabelingApproval
April 17LEVOFLOXACIN ANDA #200560SUPPL-11MYLAN ASILabelingApproval
April 17LEVOFLOXACIN ANDA #202590SUPPL-6EMCURE PHARMS LTDLabelingApproval
April 17MINOCYCLINE HYDROCHLORIDE ANDA #203443ORIG-2MYLAN

Tentative Approval
April 17METFORMIN HYDROCHLORIDE ANDA #206955SUPPL-12MACLEODS

PHARMS LTD

Manufacturing (CMC)Approval
April 17LOTEPREDNOL ETABONATE ANDA #207609ORIG-1HI TECH

Approval
April 17FLUTICASONE PROPIONATE ANDA #208024ORIG-1HI TECH

Approval
April 17AZITHROMYCIN ANDA #208250ORIG-1CSPC OUYI

Approval
April 17DULOXETINE HYDROCHLORIDE ANDA #210599ORIG-1QINGDAO BAHEAL PHARM

Approval
April 17AMPHETAMINE SULFATE ANDA #211639ORIG-1AUROLIFE PHARMA LLC

Approval
April 17OGIVRI BLA #761074SUPPL-4MYLAN GMBH

Approval
April 18CIPROFLOXACIN IN DEXTROSE 5% ANDA #076757SUPPL-8HIKMA FARMACEUTICALabelingApproval
April 18OPDIVO BLA #125554SUPPL-70BRISTOL MYERS SQUIBB

Approval
April 18BLINCYTO BLA #125557SUPPL-15AMGEN

Approval
April 18BLINCYTO BLA #125557SUPPL-16AMGEN

Approval
April 18DONEPEZIL HYDROCHLORIDE ANDA #203114SUPPL-1OSMOTICA PHARM USLabelingApproval
April 18FINGOLIMOD ANDA #207945ORIG-1EZRA VENTURES LLC

Tentative Approval
April 18NERLYNX NDA #208051SUPPL-3PUMA BIOTECHLabelingApproval
April 18BUSULFAN ANDA #210931ORIG-1SHILPA MEDICARE LTD

Approval
April 18BUDESONIDE NDA #211929ORIG-1SUN PHARMA GLOBALType 5 - New Formulation or New ManufacturerTentative Approval
April 19CLEOCIN NDA #050537SUPPL-40PHARMACIA AND UPJOHNLabelingApproval
April 19CLEOCIN T NDA #050537SUPPL-40PHARMACIA AND UPJOHNLabelingApproval
April 19CLEOCIN T NDA #050600SUPPL-17PHARMACIA AND UPJOHNLabelingApproval
April 19CLEOCIN T NDA #050615SUPPL-18PHARMACIA AND UPJOHNLabelingApproval
April 19KEYTRUDA BLA #125514SUPPL-54MERCK SHARP DOHME

Approval
April 19VALRUBICIN ANDA #206430ORIG-1CUSTOPHARM INC

Approval
April 19NATEGLINIDE ANDA #206432ORIG-1CADILA PHARMS LTD

Approval
April 19MESALAMINE ANDA #207448ORIG-1PHARM SOURCING

Approval
April 19FENOFIBRATE (MICRONIZED) ANDA #207564ORIG-1INGENUS PHARMS LLC

Approval
April 19FINGOLIMOD ANDA #207991ORIG-1ACCORD HLTHCARE INC

Tentative Approval
April 19AMOXICILLIN AND CLAVULANATE POTASSIUM ANDA #209371ORIG-1AUROBINDO PHARMA LTD

Approval
April 19NALOXONE HYDROCHLORIDE ANDA #209522ORIG-1TEVA PHARMS USA

Approval
April 19TERIFLUNOMIDE ANDA #209572ORIG-1ALEMBIC PHARMS LTD

Approval
April 19ZOLEDRONIC ACID ANDA #209578ORIG-1GLAND PHARMA LTD

Tentative Approval
April 19EVEROLIMUS ANDA #210130ORIG-1MYLAN PHARMS INC

Approval
April 19HALOBETASOL PROPIONATE NDA #210566SUPPL-1MAYNE PHARMALabelingApproval
April 19TOBRAMYCIN ANDA #211847ORIG-1ALEMBIC PHARMS LTD

Approval
April 22IMPLANON NDA #021529SUPPL-18ORGANON USA INCLabelingApproval
April 22NEXPLANON NDA #021529SUPPL-18ORGANON USA INCLabelingApproval
April 22MINOXIDIL (FOR MEN) ANDA #209074ORIG-2TARO PHARM

Approval
April 22MINOXIDIL (FOR WOMEN) ANDA #209074ORIG-2TARO PHARM

Approval
April 22CORLANOR NDA #209964ORIG-1AMGEN INCType 3 - New Dosage FormApproval
April 22DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE ANDA #211547ORIG-1SPECGX LLC

Approval
April 23ALLOPURINOL ANDA #018659SUPPL-24MYLANLabelingApproval
April 23THYRO-TABS NDA #021116SUPPL-17ALVOGENLabelingApproval
April 23AMRIX NDA #021777SUPPL-17TEVA PHARMS INTLLabelingApproval
April 23AZATHIOPRINE ANDA #074069SUPPL-14AMNEAL PHARMS LLCLabelingApproval
April 23AZATHIOPRINE ANDA #075568SUPPL-27MYLANLabelingApproval
April 23AZATHIOPRINE ANDA #077621SUPPL-13ZYDUS PHARMS USALabelingApproval
April 23ALLOPURINOL ANDA #078253SUPPL-12NORTHSTAR HLTHCARELabelingApproval
April 23TELMISARTAN ANDA #078710SUPPL-4CIPLALabelingApproval
April 23CAMPATH BLA #103948SUPPL-5168GENZYME

Approval
April 23LEMTRADA BLA #103948SUPPL-5168GENZYME

Approval
April 23ERBITUX BLA #125084SUPPL-273IMCLONE

Approval
April 23METHSCOPOLAMINE BROMIDE ANDA #200602SUPPL-5BAYSHORE PHARMS LLCManufacturing (CMC)Approval
April 23TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #201192SUPPL-6TORRENTLabelingApproval
April 23IRBESARTAN ANDA #201531SUPPL-6LUPIN LTDLabelingApproval
April 23DONEPEZIL HYDROCHLORIDE ANDA #202782SUPPL-3LUPIN LTDLabelingApproval
April 23SILDENAFIL CITRATE ANDA #203814SUPPL-5MACLEODS

PHARMS LTD

LabelingApproval
April 23SILDENAFIL CITRATE ANDA #203814SUPPL-9MACLEODS

PHARMS LTD

LabelingApproval
April 23SILDENAFIL CITRATE ANDA #203814SUPPL-12MACLEODS

PHARMS LTD

LabelingApproval
April 23OPSUMIT NDA #204410SUPPL-17ACTELION PHARMS LTDLabelingApproval
April 23GLIPIZIDE ANDA #204720SUPPL-4UNIQUE PHARM LABSLabelingApproval
April 23IRBESARTAN ANDA #204740SUPPL-1AMNEAL PHARMSLabelingApproval
April 23ENTECAVIR ANDA #205824SUPPL-2ACCORD HLTHCARELabelingApproval
April 23ENTECAVIR ANDA #205824SUPPL-3ACCORD HLTHCARELabelingApproval
April 23RUFINAMIDE ANDA #207363ORIG-1HIKMA

Approval
April 23NYSTATIN ANDA #209114SUPPL-1ACP NIMBLEManufacturing (CMC)Approval
April 23ALLOPURINOL ANDA #210117SUPPL-1ZYDUS PHARMSLabelingApproval
April 23RUFINAMIDE ANDA #211388ORIG-1BIONPHARMA INC

Approval
April 23SKYRIZI BLA #761105ORIG-1ABBVIE INC

Approval
April 24VIREAD NDA #021356SUPPL-58GILEAD SCIENCES INCLabelingApproval
April 24VIREAD NDA #022577SUPPL-14GILEAD SCIENCES INCLabelingApproval
April 24ZITHROMAX NDA #050670SUPPL-34PFIZERLabelingApproval
April 24ZITHROMAX NDA #050693SUPPL-31PFIZERLabelingApproval
April 24ZITHROMAX NDA #050710SUPPL-49PFIZERLabelingApproval
April 24ZITHROMAX NDA #050711SUPPL-47PFIZERLabelingApproval
April 24ZITHROMAX NDA #050730SUPPL-41PFIZERLabelingApproval
April 24ZITHROMAX NDA #050733SUPPL-47PFIZERLabelingApproval
April 24ZITHROMAX NDA #050784SUPPL-34PFIZERLabelingApproval
April 24ZMAX NDA #050797SUPPL-25PF PRISM CVLabelingApproval
April 24LEVOFLOXACIN ANDA #076710SUPPL-9DR REDDYS LABS INCLabelingApproval
April 24LEVOFLOXACIN ANDA #076710SUPPL-10DR REDDYS LABS INCLabelingApproval
April 24LEVOFLOXACIN ANDA #076710SUPPL-12DR REDDYS LABS INCLabelingApproval
April 24LEVOFLOXACIN ANDA #076710SUPPL-13DR REDDYS LABS INCLabelingApproval
April 24LEVOFLOXACIN ANDA #076890SUPPL-8CIPLA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #076890SUPPL-9CIPLA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #076890SUPPL-13CIPLA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #076890SUPPL-14CIPLA LTDLabelingApproval
April 24CIPROFLOXACIN EXTENDED RELEASE ANDA #077417SUPPL-7ACTAVIS LABS FL INCLabelingApproval
April 24CIPROFLOXACIN EXTENDED RELEASE ANDA #077701SUPPL-13DR REDDYS LABS LTDLabelingApproval
April 24CIPROFLOXACIN EXTENDED RELEASE ANDA #077809SUPPL-7ACTAVIS LABS FL INCLabelingApproval
April 24CIPROFLOXACIN EXTENDED RELEASE ANDA #078712SUPPL-4FOSUN PHARMALabelingApproval
April 24LEVOFLOXACIN ANDA #090787SUPPL-6APOTEX INCLabelingApproval
April 24LEVOFLOXACIN ANDA #090787SUPPL-7APOTEX INCLabelingApproval
April 24LEVOFLOXACIN ANDA #090787SUPPL-8APOTEX INCLabelingApproval
April 24LEVOFLOXACIN ANDA #090787SUPPL-9APOTEX INCLabelingApproval
April 24LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #200674SUPPL-4FRESENIUS KABI USALabelingApproval
April 24LEVOFLOXACIN ANDA #201043SUPPL-11AUROBINDO PHARMA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #201043SUPPL-12AUROBINDO PHARMA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #201043SUPPL-14AUROBINDO PHARMA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #201043SUPPL-15AUROBINDO PHARMA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #201043SUPPL-16AUROBINDO PHARMA LTDLabelingApproval
April 24LEVOFLOXACIN ANDA #202801SUPPL-1HETERO LABS LTD VLabelingApproval
April 24LEVOFLOXACIN ANDA #202801SUPPL-3HETERO LABS LTD VLabelingApproval
April 24LEVOFLOXACIN ANDA #202801SUPPL-4HETERO LABS LTD VLabelingApproval
April 24TESTOSTERONE ANDA #204255SUPPL-2PERRIGO ISRAELLabelingApproval
April 24TESTOSTERONE ANDA #204255SUPPL-3PERRIGO ISRAELLabelingApproval
April 24TESTOSTERONE CYPIONATE ANDA #206368ORIG-1WILSHIRE PHARMS INC

Approval
April 24ROSUVASTATIN CALCIUM ANDA #206381ORIG-1SCIEGEN PHARMS INC

Approval
April 24PENTAMIDINE ISETHIONATE ANDA #206667ORIG-1SETON PHARMS

Approval
April 24PROMACTA KIT NDA #207027SUPPL-8NOVARTIS PHARMS CORPLabelingApproval
April 24CISATRACURIUM BESYLATE ANDA #209132ORIG-1SOMERSET THERAPS LLC

Approval
April 24TERIFLUNOMIDE ANDA #209623ORIG-1MSN LABS PVT LTD

Approval
April 24BUMETANIDE ANDA #209916SUPPL-1UPSHER SMITH LABSLabelingApproval
April 24MEDROXY-PROGESTERONE ACETATE ANDA #210761ORIG-1SUN PHARM

Approval
April 24METHYLPHENIDATE HYDROCHLORIDE ANDA #211918ORIG-1ANDOR PHARMS

Approval
April 24LEFLUNOMIDE ANDA #212308ORIG-1ZYDUS

Approval
April 25PROTONIX NDA #020987SUPPL-55WYETH PHARMSLabelingApproval
April 25 PROTONIX IV NDA #020988SUPPL-61WYETH PHARMSLabelingApproval
April 25VELCADE NDA #021602SUPPL-44MILLENNIUM PHARMSEfficacyApproval
April 25PROTONIX NDA #022020SUPPL-17WYETH PHARMSLabelingApproval
April 25CEFTIN NDA #050605SUPPL-51GLAXOSMITHKLINELabelingApproval
April 25CEFTIN NDA #050672SUPPL-37GLAXOSMITHKLINELabelingApproval
April 25IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #091370SUPPL-8ALEMBIC PHARMS LTDLabelingApproval
April 25IRBESARTAN AND HYDROCHLOROTHIAZIDE ANDA #091370SUPPL-13ALEMBIC PHARMS LTDLabelingApproval
April 25DAUNORUBICIN HYDROCHLORIDE ANDA #206195ORIG-1HISUN PHARM HANGZHOU

Approval
April 25CLARITHROMYCIN ANDA #206714ORIG-1AJANTA PHARMA LTD

Approval
April 25DUOBRII NDA #209354ORIG-1BAUSCH HEALTH AMERICAS INCType 5 - New Formulation or New ManufacturerApproval
April 25LINEZOLID ANDA #210702ORIG-1CELLTRION

Approval
April 25CISATRACURIUM BESYLATE PRESERVATIVE FREE ANDA #211668ORIG-1NANJING KING-FRIEND

Approval
April 25CISATRACURIUM BESYLATE ANDA #211669ORIG-1NANJING KING-FRIEND

Approval
April 25ETICOVO BLA #761066ORIG-1SAMSUNG BIOEPIS CO LTD

Approval
April 26CARDIOGEN-82 NDA #019414SUPPL-22BRACCOLabelingApproval
April 26TRACLEER NDA #021290SUPPL-32ACTELION PHARMS LTDREMSApproval
April 26LEVOFLOXACIN ANDA #076276SUPPL-5MYLANLabelingApproval
April 26LEVOFLOXACIN ANDA #076276SUPPL-6MYLANLabelingApproval
April 26LEVOFLOXACIN ANDA #076276SUPPL-7MYLANLabelingApproval
April 26LEVOFLOXACIN ANDA #076361SUPPL-10TEVALabelingApproval
April 26LEVOFLOXACIN ANDA #077438SUPPL-11SANDOZLabelingApproval
April 26LEVOFLOXACIN ANDA #077438SUPPL-12SANDOZLabelingApproval
April 26LEVOFLOXACIN ANDA #077438SUPPL-15SANDOZLabelingApproval
April 26LEVOFLOXACIN ANDA #077438SUPPL-16SANDOZLabelingApproval
April 26CIPROFLOXACIN ANDA #077782SUPPL-16TEVA PHARMS USALabelingApproval
April 26CIPROFLOXACIN ANDA #077782SUPPL-18TEVA PHARMS USALabelingApproval
April 26CIPROFLOXACIN ANDA #077782SUPPL-19TEVA PHARMS USALabelingApproval
April 26CIPROFLOXACIN EXTENDED RELEASE ANDA #078166SUPPL-12ANCHEN PHARMSLabelingApproval
April 26CIPROFLOXACIN EXTENDED RELEASE ANDA #078183SUPPL-18MYLAN PHARMS INCLabelingApproval
April 26CIPROFLOXACIN EXTENDED RELEASE ANDA #078183SUPPL-20MYLAN PHARMS INCLabelingApproval
April 26BENLYSTA BLA #125370SUPPL-64HUMAN GENOME SCIENCES INC.

Approval
April 26PRALUENT BLA #125559SUPPL-19SANOFI AVENTIS

Approval
April 26PRALUENT BLA #125559SUPPL-20SANOFI AVENTIS

Approval
April 26EZETIMIBE ANDA #201790ORIG-1MYLAN

Approval
April 26RUBY-FILL NDA #202153SUPPL-12JUBILANT DRAXIMAGELabelingApproval
April 26LEVOFLOXACIN ANDA #202200SUPPL-4ORCHID HLTHCARELabelingApproval
April 26LEVOFLOXACIN ANDA #202200SUPPL-5ORCHID HLTHCARELabelingApproval
April 26LEVOFLOXACIN ANDA #202200SUPPL-6ORCHID HLTHCARELabelingApproval
April 26LEVOFLOXACIN ANDA #202200SUPPL-7ORCHID HLTHCARELabelingApproval
April 26NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #205588SUPPL-3LUPIN LTDLabelingApproval
April 26BOSENTAN ANDA #205699ORIG-1PAR PHARM INC

Approval
April 26BOSENTAN ANDA #206002ORIG-1ALVOGEN PINE BROOK

Approval
April 26BOSENTAN ANDA #206987ORIG-1NATCO PHARMA LTD

Approval
April 26BOSENTAN ANDA #207110ORIG-1WATSON LABS INC

Approval
April 26BOSENTAN ANDA #207760ORIG-1ZYDUS PHARMS

Approval
April 26BOSENTAN ANDA #208695ORIG-1WEST-WARD PHARMS INT

Approval
April 26TRACLEER NDA #209279SUPPL-4ACTELION PHARMSREMSApproval
April 26BOSENTAN ANDA #209324ORIG-1SUN PHARM

Approval
April 26AZACITIDINE ANDA #209540SUPPL-1CIPLALabelingApproval
April 26BOSENTAN ANDA #209742ORIG-1AMNEAL PHARMS CO

Approval
April 26POTASSIUM CHLORIDE ANDA #210098ORIG-1PII

Approval
April 26CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #210507ORIG-1UNICHEM LABS LTD

Tentative Approval
April 26AMBRISENTAN ANDA #210715ORIG-1CIPLA

Approval
April 26ZURAGARD NDA #210872ORIG-1ZUREX PHARMAType 5 - New Formulation or New ManufacturerApproval
April 26TRIENTINE HYDROCHLORIDE ANDA #211554ORIG-1ZYDUS PHARMS

Approval
April 26DICYCLOMINE HYDROCHLORIDE ANDA #212058ORIG-1SUNGEN PHARMA

Approval
April 26BENLYSTA BLA #761043SUPPL-7GLAXOSMITHKLINE LLC

Approval
April 27MERREM NDA #050706SUPPL-41PFIZERLabelingApproval
April 29ARGATROBAN IN SODIUM CHLORIDE NDA #022485SUPPL-13SANDOZLabelingApproval
April 29PIRMELLA 7/7/7 ANDA #201510SUPPL-11LUPIN LTDManufacturing (CMC)Approval
April 29PIRMELLA 1/35 ANDA #201512SUPPL-11LUPIN LTDManufacturing (CMC)Approval
April 29KALYDECO NDA #203188SUPPL-29VERTEX PHARMSEfficacyApproval
April 29FELODIPINE ANDA #204800ORIG-1YUNG SHIN PHARM

Approval
April 29TADALAFIL ANDA #206956ORIG-1MYLAN

Approval
April 29TADALAFIL ANDA #206957ORIG-1MYLAN

Approval
April 29KALYDECO NDA #207925SUPPL-8VERTEX PHARMS INCEfficacyApproval
April 29OLOPATADINE HYDROCHLORIDE ANDA #209420ORIG-1ALEMBIC PHARMS LTD

Approval
April 29VANCOMYCIN HYDROCHLORIDE ANDA #210729ORIG-1ORIENT PHARMA CO LTD

Approval
April 30VFEND NDA #021266SUPPL-45PF PRISM CVLabelingApproval
April 30VFEND NDA #021267SUPPL-55PF PRISM CVLabelingApproval
April 30VESICARE NDA #021518SUPPL-18ASTELLASLabelingApproval
April 30VFEND NDA #021630SUPPL-34PF PRISM CVLabelingApproval
April 30INTUNIV NDA #022037SUPPL-18SHIRELabelingApproval
April 30BICILLIN C-R NDA #050138SUPPL-240KING PHARMS LLCLabelingApproval
April 30BICILLIN C-R 900/300 NDA #050138SUPPL-240KING PHARMS LLCLabelingApproval
April 30BICILLIN L-A NDA #050141SUPPL-237KING PHARMS LLCLabelingApproval
April 30OFLOXACIN ANDA #076182SUPPL-17TEVALabelingApproval
April 30PROLIA BLA #125320SUPPL-200AMGEN

Approval
April 30XGEVA BLA #125320SUPPL-200AMGEN

Approval
April 30MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER ANDA #205833SUPPL-6MYLAN LABS LTDLabelingApproval
April 30E-Z-CAT DRY NDA #208036SUPPL-10BRACCOEfficacyApproval
April 30E-Z-HD NDA #208036SUPPL-10BRACCOEfficacyApproval
April 30E-Z-PAQUE NDA #208036SUPPL-10BRACCOEfficacyApproval
April 30LUMIFY NDA #208144SUPPL-2BAUSCH AND LOMB INCLabelingApproval
April 30SELENIOUS ACID NDA #209379ORIG-1AMERICAN REGENT INCType 2 - New Active IngredientApproval
April 30MAVYRET NDA #209394SUPPL-6ABBVIE INCEfficacyApproval
April 30BOSUTINIB ANDA #209577ORIG-1SUN PHARM INDUSTRIES

Tentative Approval
April 30POTASSIUM CHLORIDE ANDA #209922ORIG-1PRINSTON INC

Approval
April 30NITROGLYCERIN ANDA #211604ORIG-1ALVOGEN MALTA

Approval
Source: U.S. Food and Drug Administration

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