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The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.
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 March
| Drug Name | Submission | Active Ingredients | Company | Submission Classification | Submission Status |
| ROBAXIN NDA #011011 | SUPPL-79 | METHOCARBAMOL | AUXILIUM PHARMS LLC | Labeling | Approval |
| ROBAXIN-750 NDA
#011011 | SUPPL-79 | METHOCARBAMOL | AUXILIUM PHARMS LLC | Labeling | Approval |
| TRANSDERM SCOP NDA #017874 | SUPPL-43 | SCOPOLAMINE | GLAXOSMITHKLINE CON | Efficacy | Approval |
| TRANSDERM SCOP NDA #017874 | SUPPL-44 | SCOPOLAMINE | GLAXOSMITHKLINE CON | Labeling | Approval |
| ZOCOR NDA #019766 | SUPPL-92 | SIMVASTATIN | MSD MERCK CO | Labeling | Approval |
| SUPRANE NDA #020118 | SUPPL-22 | DESFLURANE | BAXTER HLTHCARE | Manufacturing (CMC) | Approval |
| SUPRANE NDA #020118 | SUPPL-23 | DESFLURANE | BAXTER HLTHCARE | Labeling | Approval |
| CLARINEX NDA #021165 | SUPPL-20 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| FLECTOR NDA #021234 | SUPPL-16 | DICLOFENAC EPOLAMINE | INST BIOCHEM | Efficacy | Approval |
| FLECTOR NDA #021234 | SUPPL-17 | DICLOFENAC EPOLAMINE | INST BIOCHEM | Labeling | Approval |
| CLARINEX NDA #021300 | SUPPL-17 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX NDA #021312 | SUPPL-18 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX NDA #021563 | SUPPL-6 | DESLORATADINE | SCHERING | Labeling | Approval |
| FENOFIBRATE ANDA #076509 | SUPPL-31 | FENOFIBRATE | IMPAX LABS | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #076706 | SUPPL-14 | METFORMIN HYDROCHLORIDE | APOTEX | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #076706 | SUPPL-16 | METFORMIN HYDROCHLORIDE | APOTEX | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #076864 | SUPPL-15 | METFORMIN HYDROCHLORIDE | TEVA | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #076864 | SUPPL-16 | METFORMIN HYDROCHLORIDE | TEVA | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #077336 | SUPPL-12 | METFORMIN HYDROCHLORIDE | SUN PHARM INDS (IN) | Labeling | Approval |
| METFORMIN HYDROCHLORIDE ANDA #077336 | SUPPL-15 | METFORMIN HYDROCHLORIDE | SUN PHARM INDS (IN) | Labeling | Approval |
| BUSPIRONE HYDROCHLORIDE ANDA #204582 | SUPPL-1 | BUSPIRONE HYDROCHLORIDE | HERITAGE PHARMA | Labeling | Approval |
| BUSPIRONE HYDROCHLORIDE ANDA #204582 | SUPPL-2 | BUSPIRONE HYDROCHLORIDE | HERITAGE PHARMA | Manufacturing (CMC) | Approval |
| PERPHENAZINE ANDA #205056 | ORIG-1 | PERPHENAZINE | RISING PHARMS | Approval | |
| ROSUVASTATIN CALCIUM ANDA #206513 | ORIG-1 | ROSUVASTATIN CALCIUM | ZYDUS PHARMS | Approval | |
| IMATINIB MESYLATE ANDA #207818 | ORIG-1 | IMATINIB MESYLATE | NATCO PHARMA LTD | Approval | |
| PHENYLEPHRINE HYDROCHLORIDE NDA #207926 | SUPPL-2 | PHENYLEPHRINE HYDROCHLORIDE | AKORN INC | Labeling | Approval |
| XHANCE NDA #209022 | SUPPL-6 | FLUTICASONE PROPIONATE | OPTINOSE US INC | Manufacturing (CMC) | Approval |
| DAPSONE ANDA #209430 | ORIG-1 | DAPSONE | TARO PHARM | Approval | |
| PANTOPRAZOLE SODIUM ANDA #211368 | ORIG-1 | PANTOPRAZOLE SODIUM | INGENUS PHARMS LLC | Approval | |
| LUPRON DEPOT NDA #019732 | SUPPL-44 | LEUPROLIDE ACETATE | ABBVIE ENDOCRINE INC | Labeling | Approval |
| LUPRON DEPOT NDA #020517 | SUPPL-42 | LEUPROLIDE ACETATE | ABBVIE ENDOCRINE INC | Labeling | Approval |
| TELMISARTAN AND HYDRO-
CHLOROTHIAZIDE ANDA #202544 | ORIG-1 | HYDRO-
CHLOROTHIAZIDE; TELMISARTAN | GLENMARK PHARMS LTD | Approval | |
| DESVENLAFAXINE SUCCINATE ANDA #204003 | SUPPL-6 | DESVENLAFAXINE SUCCINATE | ALEMBIC PHARMS LTD | Labeling | Approval |
| ALISKIREN HEMIFUMARATE; HYDRO- CHLOROTHIAZIDE ANDA #205769 | ORIG-1 | ALISKIREN HEMIFUMARATE; HYDRO- CHLOROTHIAZIDE | PAR PHARM INC | Tentative Approval | |
| RIVASTIGMINE ANDA #206318 | ORIG-1 | RIVASTIGMINE | ZYDUS NOVELTECH INC | Approval | |
| NUPLAZID NDA #207318 | SUPPL-6 | PIMAVANSERIN TARTRATE | ACADIA PHARMS INC | Labeling | Approval |
| FULVESTRANT ANDA #210044 | ORIG-1 | FULVESTRANT | AMNEAL PHARMS CO | Approval | |
| NUPLAZID NDA #210793 | SUPPL-1 | PIMAVANSERIN TARTRATE | ACADIA PHARMS INC | Labeling | Approval |
| CLOBETASOL PROPIONATE ANDA #211800 | ORIG-1 | CLOBETASOL PROPIONATE | ALEOR DERMACEUTICALS | Approval | |
| LAMIVUDINE ANDA #078545 | ORIG-1 | LAMIVUDINE | MYLAN LABS LTD | Approval | |
| ZYKADIA NDA #205755 | SUPPL-16 | CERITINIB | NOVARTIS PHARMS CORP | Labeling | Approval |
| BEPOTASTINE BESILATE ANDA #206066 | ORIG-1 | BEPOTASTINE BESILATE | APOTEX INC | Approval | |
| ESOMEPRAZOLE MAGNESIUM ANDA #209202 | ORIG-1 | ESOMEPRAZOLE MAGNESIUM | ACTAVIS ELIZABETH | Approval | |
| CLONIDINE HYDROCHLORIDE ANDA #209675 | ORIG-1 | CLONIDINE HYDROCHLORIDE | NOVAST LABS | Approval | |
| PREVYMIS NDA #209939 | SUPPL-3 | LETERMOVIR | MERCK SHARP DOHME | Labeling | Approval |
| PREVYMIS NDA #209940 | SUPPL-1 | LETERMOVIR | MERCK SHARP DOHME | Labeling | Approval |
| SPRAVATO NDA #211243 | ORIG-1 | ESKETAMINE | JANSSEN PHARMS | Type 2 - New Active Ingredient | Approval |
| SIMVASTATIN ANDA #078034 | SUPPL-12 | SIMVASTATIN | BIOCON LIMITED | Labeling | Approval |
| CARVEDILOL ANDA #078251 | SUPPL-18 | CARVEDILOL | GLENMARK GENERICS | Labeling | Approval |
| TRANEXAMIC ACID ANDA #201885 | SUPPL-6 | TRANEXAMIC ACID | LUITPOLD | Labeling | Approval |
| BUMETANIDE ANDA #202900 | SUPPL-1 | BUMETANIDE | ZYDUS PHARMS | Labeling | Approval |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #204802 | SUPPL-5 | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | MACLEODS PHARMS LTD | Labeling | Approval |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #204802 | SUPPL-8 | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE | MACLEODS PHARMS LTD | Labeling | Approval |
| ATORVASTATIN CALCIUM ANDA #204991 | ORIG-1 | ATORVASTATIN CALCIUM | LUPIN LTD | Approval | |
| SIVEXTRO NDA #205435 | SUPPL-10 | TEDIZOLID PHOSPHATE | CUBIST PHARMS LLC | Efficacy | Approval |
| SIVEXTRO NDA #205436 | SUPPL-5 | TEDIZOLID PHOSPHATE | CUBIST PHARMS LLC | Efficacy | Approval |
| CALCITRIOL ANDA #211030 | ORIG-1 | CALCITRIOL | GLAND PHARMA LTD | Tentative Approval | |
| SOLIFENACIN SUCCINATE ANDA #211657 | ORIG-1 | SOLIFENACIN SUCCINATE | SCIEGEN PHARMS INC | Tentative Approval | |
| IMODIUM A-D NDA #019860 | SUPPL-33 | LOPERAMIDE HYDROCHLORIDE | J AND J CONSUMER INC | Labeling | Approval |
| OPDIVO BLA #125554 | SUPPL-42 | NIVOLUMAB | BRISTOL MYERS SQUIBB | Approval | |
| ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE ANDA #210899 | ORIG-1 | ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE | LAURUS LABS LTD | Tentative Approval | |
| HALDOL NDA #015923 | SUPPL-95 | HALOPERIDOL LACTATE | JANSSEN PHARMS | Labeling | Approval |
| HALDOL NDA #018701 | SUPPL-73 | HALOPERIDOL DECANOATE | JANSSEN PHARMS | Labeling | Approval |
| SPORANOX NDA #020083 | SUPPL-63 | ITRACONAZOLE | JANSSEN PHARMS | Labeling | Approval |
| SPORANOX NDA #020657 | SUPPL-37 | ITRACONAZOLE | JANSSEN PHARMS | Labeling | Approval |
| PARSABIV NDA #208325 | SUPPL-2 | ETELCALCETIDE | KAI PHARMS INC | Labeling | Approval |
| TOFACITINIB ANDA #209790 | ORIG-1 | TOFACITINIB | SUN PHARM INDS LTD | Tentative Approval | |
| ATENOLOL AND CHLORTHALIDONE ANDA #210028 | ORIG-1 | ATENOLOL; CHLORTHALIDONE | ZYDUS PHARMS | Approval | |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #211023 | ORIG-1 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | WES PHARMA INC | Approval | |
| FOLIC ACID ANDA #211064 | ORIG-1 | FOLIC ACID | INVATECH PHARMA | Approval | |
| PYRIDOSTIGMINE BROMIDE ANDA #211694 | ORIG-1 | PYRIDOSTIGMINE BROMIDE | NOVITIUM PHARMA | Approval | |
| TECENTRIQ BLA #761034 | SUPPL-18 | ATEZOLIZUMAB | GENENTECH INC | Approval | |
| TORSEMIDE ANDA #076110 | SUPPL-6 | TORSEMIDE | TEVA | Labeling | Approval |
| ENTECAVIR ANDA #206217 | SUPPL-2 | ENTECAVIR | AUROBINDO PHARMA LTD | Labeling | Approval |
| ENTECAVIR ANDA #206217 | SUPPL-5 | ENTECAVIR | AUROBINDO PHARMA LTD | Labeling | Approval |
| ENTECAVIR ANDA #206217 | SUPPL-6 | ENTECAVIR | AUROBINDO PHARMA LTD | Labeling | Approval |
| ENTECAVIR ANDA #206217 | SUPPL-7 | ENTECAVIR | AUROBINDO PHARMA LTD | Labeling | Approval |
| ASPIRIN AND DIPYRIDAMOLE
ANDA #206753 | SUPPL-2 | ASPIRIN; DIPYRIDAMOLE | ZYDUS PHARMS | Labeling | Approval |
| ASPIRIN AND DIPYRIDAMOLE ANDA #209048 | SUPPL-1 | ASPIRIN; DIPYRIDAMOLE | DR REDDYS LABS LTD | Labeling | Approval |
| FASLODEX NDA #021344 | SUPPL-37 | FULVESTRANT | ASTRAZENECA | Efficacy | Approval |
| NOXAFIL NDA #022003 | SUPPL-24 | POSACONAZOLE | SCHERING | Labeling | Approval |
| PROCHLOR-
PERAZINE EDISYLATE ANDA #040540 | SUPPL-16 | PROCHLOR-
PERAZINE EDISYLATE | ATHENEX INC | Manufacturing (CMC) | Approval |
| NIKKI ANDA #201661 | SUPPL-1 | DROSPIRENONE; ETHINYL ESTRADIOL | LUPIN LTD | Labeling | Approval |
| NIKKI ANDA #201661 | SUPPL-4 | DROSPIRENONE; ETHINYL ESTRADIOL | LUPIN LTD | Labeling | Approval |
| NIKKI ANDA #201661 | SUPPL-6 | DROSPIRENONE; ETHINYL ESTRADIOL | LUPIN LTD | Manufacturing (CMC) | Approval |
| MAGNESIUM SULFATE ANDA #202411 | SUPPL-2 | MAGNESIUM SULFATE | HOSPIRA INC | Manufacturing (CMC) | Approval |
| EPTIFIBATIDE ANDA #204362 | ORIG-1 | EPTIFIBATIDE | USV | Approval | |
| NOXAFIL NDA #205053 | SUPPL-8 | POSACONAZOLE | MERCK SHARP DOHME | Labeling | Approval |
| NOXAFIL NDA #205596 | SUPPL-7 | POSACONAZOLE | MERCK SHARP DOHME | Labeling | Approval |
| POTASSIUM CHLORIDE ANDA #208445 | ORIG-1 | POTASSIUM CHLORIDE | ZYDUS PHARMS | Approval | |
| BRIMONIDINE TARTRATE ANDA #208992 | ORIG-1 | BRIMONIDINE TARTRATE | SOMERSET THERAPS LLC | Approval | |
| BLEOMYCIN SULFATE ANDA #209439 | ORIG-1 | BLEOMYCIN SULFATE | CIPLA | Approval | |
| ENZALUTAMIDE ANDA #209614 | ORIG-1 | ENZALUTAMIDE | ACTAVIS LABS FL INC | Tentative Approval | |
| DALFAMPRIDINE ANDA #210158 | ORIG-1 | DALFAMPRIDINE | MICRO LABS | Approval | |
| DUPIXENT BLA #761055 | SUPPL-12 | DUPILUMAB | REGENERON PHARMACEUTICALS | Approval | |
| AIMOVIG BLA #761077 | SUPPL-1 | ERENUMAB-AOOE | AMGEN INC | Approval | |
| TRAZIMERA BLA #761081 | ORIG-1 | TRASTUZUMAB-
QYYP | PFIZER INC | Approval | |
| VISIPAQUE 270 NDA #020351 | SUPPL-48 | IODIXANOL | GE HEALTHCARE | Labeling | Approval |
| VISIPAQUE 320 NDA #020351 | SUPPL-48 | IODIXANOL | GE HEALTHCARE | Labeling | Approval |
| BIDIL NDA #020727 | SUPPL-10 | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE | ARBOR PHARMS LLC | Labeling | Approval |
| VISIPAQUE 270 NDA #020808 | SUPPL-28 | IODIXANOL | GE HEALTHCARE | Labeling | Approval |
| VISIPAQUE 320 NDA #020808 | SUPPL-28 | IODIXANOL | GE HEALTHCARE | Labeling | Approval |
| APRISO NDA #022301 | SUPPL-14 | MESALAMINE | VALEANT PHARMS INTL | Labeling | Approval |
| VALSARTAN ANDA #205536 | ORIG-1 | VALSARTAN | ALKEM LABS LTD | Approval | |
| LORATADINE ANDA #207569 | ORIG-1 | LORATADINE | NEWGEN PHARMS LLC | Approval | |
| ROCKLATAN NDA #208259 | ORIG-1 | NETARSUDIL; LATANOPROST | AERIE PHARMS INC | Approval | |
| TIZANIDINE HYDROCHLORIDE ANDA #210267 | ORIG-1 | TIZANIDINE HYDROCHLORIDE | RICONPHARMA LLC | Approval | |
| NIFEDIPINE ANDA #210614 | ORIG-1 | NIFEDIPINE | NOVAST LABS | Approval | |
| TETRACAINE HYDROCHLORIDE NDA #210821 | ORIG-1 | TETRACAINE HYDROCHLORIDE | BAUSCH HEALTH IRELAND LIMITED | Type 5 - New Formulation or New Manufacturer | Approval |
| ALLOPURINOL ANDA #211820 | ORIG-1 | ALLOPURINOL | UNICHEM LABS LTD | Approval | |
| DESONIDE ANDA #212002 | ORIG-1 | DESONIDE | TELIGENT PHARMA INC | Approval | |
| NORDETTE-28 NDA #018782 | SUPPL-39 | ETHINYL ESTRADIOL; LEVONORGESTREL | TEVA BRANDED PHARM | Labeling | Approval |
| FENOGLIDE NDA #022118 | SUPPL-9 | FENOFIBRATE | SANTARUS INC | Labeling | Approval |
| KEMEYA ANDA #202138 | ORIG-1 | DROSPIRENONE; ETHINYL ESTRADIOL | SUN PHARM | Approval | |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER ANDA #209476 | ORIG-1 | SODIUM CHLORIDE | FRESENIUS KABI USA | Approval | |
| METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ANDA #209573 | ORIG-1 | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | ZYDUS PHARMS USA INC | Tentative Approval | |
| DOCETAXEL ANDA #209634 | SUPPL-2 | DOCETAXEL | CIPLA | Labeling | Approval |
| CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ANDA #210622 | ORIG-1 | CETIRIZINE HYDROCHLORIDE | HETERO LABS LTD III | Approval | |
| SOLIFENACIN SUCCINATE ANDA #211423 | ORIG-1 | SOLIFENACIN SUCCINATE | CSPC OUYI PHARM CO | Tentative Approval | |
| HELIDAC NDA #050719 | SUPPL-22 | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | CASPER PHARMA LLC | Labeling | Approval |
| EPTIFIBATIDE ANDA #204361 | ORIG-1 | EPTIFIBATIDE | USV | Approval | |
| AVYCAZ NDA #206494 | SUPPL-5 | AVIBACTAM SODIUM; CEFTAZIDIME | ALLERGAN SALES LLC | Efficacy | Approval |
| AVYCAZ NDA #206494 | SUPPL-6 | AVIBACTAM SODIUM; CEFTAZIDIME | ALLERGAN SALES LLC | Efficacy | Approval |
| ENOXAPARIN SODIUM ANDA #208600 | ORIG-1 | ENOXAPARIN SODIUM | AMPHASTAR PHARMS INC | Approval | |
| CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #209252 | ORIG-1 | BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | GLENMARK PHARMS | Approval | |
| CLARINEX NDA #021165 | SUPPL-22 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX NDA #021300 | SUPPL-19 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX NDA #021312 | SUPPL-20 | DESLORATADINE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX-D 12 HOUR NDA #021313 | SUPPL-12 | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | MERCK SHARP DOHME | Labeling | Approval |
| CLARINEX NDA #021563 | SUPPL-8 | DESLORATADINE | SCHERING | Labeling | Approval |
| CLARINEX D 24 HOUR NDA #021605 | SUPPL-17 | DESLORATADINE; PSEUDOEPHEDRINE SULFATE | MERCK SHARP DOHME | Labeling | Approval |
| APTIOM NDA #022416 | SUPPL-11 | ESLICARBAZEPINE ACETATE | SUNOVION PHARMS INC | Efficacy | Approval |
| DIFICID NDA #201699 | SUPPL-10 | FIDAXOMICIN | CUBIST PHARMS LLC | Labeling | Approval |
| VALSARTAN AND HYDRO-
CHLOROTHIAZIDE ANDA #203000 | ORIG-1 | HYDRO-
CHLOROTHIAZIDE; VALSARTAN | ZYDUS PHARMS | Approval | |
| ACYCLOVIR ANDA #205974 | ORIG-1 | ACYCLOVIR | ZYDUS PHARMS | Approval | |
| EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE NDA #210649 | ORIG-1 | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | MACLEODS PHARMS LTD | Type 5 - New Formulation or New Manufacturer | Approval |
| ALBUTEROL SULFATE ANDA #210948 | ORIG-1 | ALBUTEROL SULFATE | AIZANT | Approval | |
| AZELAIC ACID ANDA #211077 | ORIG-1 | AZELAIC ACID | PERRIGO PHARMA INTL | Tentative Approval | |
| AXITINIB ANDA #211650 | ORIG-1 | AXITINIB | APOTEX INC | Tentative Approval | |
| KYNAMRO NDA #203568 | SUPPL-11 | MIPOMERSEN SODIUM | KASTLE THERAPS LLC | Labeling | Approval |
| BEPOTASTINE BESILATE ANDA #206220 | ORIG-1 | BEPOTASTINE BESILATE | MICRO LABS | Approval | |
| FLUOCINONIDE ANDA #207554 | ORIG-1 | FLUOCINONIDE | TELIGENT PHARMA INC | Approval | |
| GENVOYA NDA #207561 | SUPPL-23 | COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | GILEAD SCIENCES INC | Labeling | Approval |
| DIAZEPAM ANDA #210363 | ORIG-1 | DIAZEPAM | BELOTECA INC | Approval | |
| ZYKADIA NDA #211225 | ORIG-1 | CERITINIB | NOVARTIS PHARMS CORP | Approval | |
| TECENTRIQ BLA #761034 | SUPPL-19 | ATEZOLIZUMAB | GENENTECH INC | Approval | |
| ALLOPURINOL ANDA #077353 | SUPPL-6 | ALLOPURINOL | APOTEX INC | Labeling | Approval |
| AMITRIPTYLINE HYDROCHLORIDE ANDA #089399 | SUPPL-45 | AMITRIPTYLINE HYDROCHLORIDE | SUN PHARM INDS INC | Manufacturing (CMC) | Approval |
| ERTAPENEM SODIUM ANDA #207647 | ORIG-1 | ERTAPENEM SODIUM | SAVIOR LIFETEC CORP | Approval | |
| LURASIDONE HYDROCHLORIDE ANDA #208052 | ORIG-1 | LURASIDONE HYDROCHLORIDE | ZYDUS PHARMS | Approval | |
| GLEOLAN NDA #208630 | SUPPL-4 | AMINOLEVULINIC ACID HYDROCHLORIDE | NXDC | Labeling | Approval |
| PREGABALIN ANDA #209664 | ORIG-1 | PREGABALIN | DR REDDYS LABS LTD | Tentative Approval | |
| ZULRESSO NDA #211371 | ORIG-1 | BREXANOLONE | SAGE THERAPEUTICS | Type 1 - New Molecular Entity | Approval |
| ASPIRIN AND DIPYRIDAMOLE ANDA #204552 | ORIG-1 | ASPIRIN; DIPYRIDAMOLE | LANNETT CO INC | Approval | |
| NAFTIFINE HYDROCHLORIDE ANDA #206165 | ORIG-1 | NAFTIFINE HYDROCHLORIDE | TOLMAR | Approval | |
| AZELASTINE HYDROCHLORIDE ANDA #209620 | ORIG-1 | AZELASTINE HYDROCHLORIDE | ALEMBIC PHARMS LTD | Approval | |
| FLUOXETINE HYDROCHLORIDE ANDA #210935 | ORIG-1 | FLUOXETINE HYDROCHLORIDE | SCIEGEN PHARMS INC | Approval | |
| SUNOSI NDA #211230 | ORIG-1 | SOLRIAMFETOL | JAZZ PHARMA IRELAND LTD | Type 1 - New Molecular Entity | Approval |
| SUNOSI NDA #211230 | ORIG-2 | SOLRIAMFETOL | JAZZ PHARMA IRELAND LTD | Type 1 - New Molecular Entity | Approval |
| METHYL-
ERGONOVINE MALEATE ANDA #211455 | ORIG-1 | METHYLERGONOVINE MALEATE | TEVA PHARMS USA | Approval | |
| GLYCO-
PYRROLATE ANDA #211705 | ORIG-1 | GLYCOPYRROLATE | CAPLIN | Approval | |
| LIBTAYO BLA #761097 | SUPPL-1 | CEMIPLIMAB-RWLC | REGENERON PHARMACEUTICALS | Approval | |
| PREZISTA NDA #021976 | SUPPL-53 | DARUNAVIR ETHANOLATE | JANSSEN PRODS | Efficacy | Approval |
| IBUPROFEN ANDA #071265 | SUPPL-46 | IBUPROFEN | CONTRACT PHARMACAL | Labeling | Approval |
| IBUPROFEN ANDA #071265 | SUPPL-48 | IBUPROFEN | CONTRACT PHARMACAL | Labeling | Approval |
| IBUPROFEN ANDA #071265 | SUPPL-49 | IBUPROFEN | CONTRACT PHARMACAL | Labeling | Approval |
| ORENCIA BLA #125118 | SUPPL-224 | ABATACEPT | BRISTOL MYERS SQUIBB | Approval | |
| PREZISTA NDA #202895 | SUPPL-24 | DARUNAVIR ETHANOLATE | JANSSEN PRODS | Efficacy | Approval |
| RIVASTIGMINE ANDA #207308 | SUPPL-1 | RIVASTIGMINE | AMNEAL PHARMS | Labeling | Approval |
| DOPTELET NDA #210238 | SUPPL-2 | AVATROMBOPAG MALEATE | AKARX INC | Labeling | Approval |
| LAMIVUDINE ANDA #211306 | ORIG-1 | LAMIVUDINE | ANNORA | Approval | |
| RENFLEXIS BLA #761054 | SUPPL-4 | INFLIXIMAB-ABDA | SAMSUNG BIOEPIS CO LTD | Approval | |
| FULPHILA BLA #761075 | SUPPL-1 | PEGFILGRASTIM-JMDB | MYLAN GMBH | Approval | |
| PHENDI-
METRAZINE TARTRATE NDA #018074 | SUPPL-36 | PHENDIMETRAZINE TARTRATE | VIRTUS PHARMS | Labeling | Approval |
| MOMETASONE FUROATE ANDA #076788 | SUPPL-10 | MOMETASONE FUROATE | TARO | Labeling | Approval |
| AMLODIPINE BESYLATE ANDA #078573 | SUPPL-17 | AMLODIPINE BESYLATE | TORRENT PHARMS | Labeling | Approval |
| PROPRANOLOL HYDROCHLORIDE ANDA #078703 | SUPPL-9 | PROPRANOLOL HYDROCHLORIDE | RP SCHERER | Manufacturing (CMC) | Approval |
| LEVALBUTEROL HYDROCHLORIDE ANDA #090297 | SUPPL-8 | LEVALBUTEROL HYDROCHLORIDE | TEVA PHARMS USA | Manufacturing (CMC) | Approval |
| PIRMELLA 7/7/7 ANDA #201510 | SUPPL-8 | ETHINYL ESTRADIOL; NORETHINDRONE | LUPIN LTD | Labeling | Approval |
| PIRMELLA 1/35 ANDA #201512 | SUPPL-8 | ETHINYL ESTRADIOL; NORETHINDRONE | LUPIN LTD | Labeling | Approval |
| BIMATOPROST ANDA #203604 | ORIG-1 | BIMATOPROST | HI-TECH PHARMACAL | Tentative Approval | |
| RANITIDINE HYDROCHLORIDE ANDA #205512 | SUPPL-8 | RANITIDINE HYDROCHLORIDE | STRIDES PHARMA | Manufacturing (CMC) | Approval |
| ALISKIREN
HEMIFUMARATE ANDA #206665 | ORIG-1 | ALISKIREN
HEMIFUMARATE | ANCHEN PHARMS | Approval | |
| ROFLUMILAST ANDA #208180 | ORIG-1 | ROFLUMILAST | MICRO LABS | Approval | |
| RHOPRESSA NDA #208254 | SUPPL-3 | NETARSUDIL DIMESYLATE | AERIE PHARMS INC | Labeling | Approval |
| EZETIMIBE AND SIMVASTATIN ANDA #208831 | SUPPL-1 | EZETIMIBE; SIMVASTATIN | AMNEAL PHARMS CO | Labeling | Approval |
| BIMATOPROST ANDA #210126 | ORIG-1 | BIMATOPROST | GLAND PHARMA LTD | Approval | |
| DIMETHYL FUMARATE ANDA #210460 | ORIG-1 | DIMETHYL FUMARATE | MSN LABORATORIES | Tentative Approval | |
| HYDROXY-
PROGESTERONE CAPROATE ANDA #210877 | ORIG-1 | HYDROXY-
PROGESTERONE CAPROATE | SLAYBACK PHARMA LLC | Approval | |
| DROSPIRENONE AND ETHINYL ESTRADIOL ANDA #211944 | ORIG-1 | DROSPIRENONE; ETHINYL ESTRADIOL | HETERO LABS LTD | Approval | |
| SILDENAFIL CITRATE ANDA #212051 | ORIG-1 | SILDENAFIL CITRATE | LUPIN LTD | Approval | |
| TACROLIMUS ANDA #065461 | SUPPL-29 | TACROLIMUS | SANDOZ | Labeling | Approval |
| TACROLIMUS ANDA #065461 | SUPPL-30 | TACROLIMUS | SANDOZ | Labeling | Approval |
| TRAZODONE HYDROCHLORIDE ANDA #071406 | SUPPL-6 | TRAZODONE HYDROCHLORIDE | MYLAN | Labeling | Approval |
| SILDENAFIL CITRATE ANDA #201171 | ORIG-1 | SILDENAFIL CITRATE | MYLAN PHARMS INC | Approval | |
| ARMODAFINIL ANDA #201514 | ORIG-1 | ARMODAFINIL | APOTEX INC | Approval | |
| AZELASTINE HYDROCHLORIDE ANDA #204660 | SUPPL-1 | AZELASTINE HYDROCHLORIDE | AMNEAL PHARMS LLC | Labeling | Approval |
| AZACITIDINE ANDA
#207518 | SUPPL-4 | AZACITIDINE | SHILPA MEDICARE | Labeling | Approval |
| IVERMECTIN ANDA
#210019 | ORIG-1 | IVERMECTIN | TEVA PHARMS USA INC | Tentative Approval | |
| DIMETHYL FUMARATE ANDA #210285 | ORIG-1 | DIMETHYL FUMARATE | SAWAI USA | Tentative Approval | |
| DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE NDA #210796 | ORIG-1 | DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE | MACLEODS PHARMS LTD | Type 4 - New Combination | Tentative Approval |
| LURASIDONE HYDROCHLORIDE ANDA #212091 | ORIG-1 | LURASIDONE HYDROCHLORIDE | PIRAMAL HLTHCARE UK | Tentative Approval | |
| H.P. ACTHAR GEL NDA #008372 | SUPPL-61 | CORTICOTROPIN | MALLINCKRODT ARD | Labeling | Approval |
| INDOCIN NDA #016059 | SUPPL-100 | INDOMETHACIN | EGALET | Labeling | Approval |
| INDOCIN NDA #017814 | SUPPL-43 | INDOMETHACIN | EGALET | Labeling | Approval |
| INDOCIN SR NDA #018185 | SUPPL-57 | INDOMETHACIN | EGALET | Labeling | Approval |
| INDOCIN NDA #018332 | SUPPL-40 | INDOMETHACIN | EGALET | Labeling | Approval |
| TAGAMET HB NDA #020238 | SUPPL-23 | CIMETIDINE | MEDTECH PRODUCTS | Labeling | Approval |
| ERIVEDGE NDA #203388 | SUPPL-14 | VISMODEGIB | GENENTECH | Labeling | Approval |
| TIVORBEX NDA #204768 | SUPPL-6 | INDOMETHACIN | EGALET | Labeling | Approval |
| TADALAFIL ANDA #204809 | ORIG-1 | TADALAFIL | ALEMBIC PHARMS LTD | Approval | |
| ENTECAVIR ANDA #206226 | ORIG-1 | ENTECAVIR | MYLAN PHARMS INC | Approval | |
| TADALAFIL ANDA #206285 | ORIG-1 | TADALAFIL | AUROBINDO PHARMA LTD | Approval | |
| TADALAFIL ANDA #206693 | ORIG-1 | TADALAFIL | ZYDUS PHARMS | Approval | |
| TADALAFIL ANDA #208934 | ORIG-1 | TADALAFIL | SUN PHARM | Approval | |
| TADALAFIL ANDA #209167 | ORIG-1 | TADALAFIL | ACCORD HLTHCARE | Approval | |
| TADALAFIL ANDA #209250 | ORIG-1 | TADALAFIL | UNICHEM LABS LTD | Approval | |
| TADALAFIL ANDA #209539 | ORIG-1 | TADALAFIL | CIPLA | Approval | |
| TADALAFIL ANDA #209654 | ORIG-1 | TADALAFIL | AJANTA PHARMA LTD | Approval | |
| TADALAFIL ANDA #209744 | ORIG-1 | TADALAFIL | AMNEAL PHARMS CO | Approval | |
| MAYZENT NDA #209884 | ORIG-1 | SIPONIMOD | NOVARTIS PHARMS CORP | Type 1 - New Molecular Entity | Approval |
| TADALAFIL ANDA #209908 | ORIG-1 | TADALAFIL | HETERO LABS LTD III | Approval | |
| TIZANIDINE HYDROCHLORIDE ANDA #210021 | ORIG-1 | TIZANIDINE HYDROCHLORIDE | CADILA PHARMS LTD | Approval | |
| TADALAFIL ANDA #210069 | ORIG-1 | TADALAFIL | DR REDDYS LABS LTD | Approval | |
| CEPHALEXIN ANDA #210221 | ORIG-1 | CEPHALEXIN | ALKEM LABS LTD | Approval | |
| TADALAFIL ANDA #210420 | ORIG-1 | TADALAFIL | QILU PHARM CO LTD | Approval | |
| TADALAFIL ANDA #210567 | ORIG-1 | TADALAFIL | LUPIN LTD | Approval | |
| TADALAFIL ANDA #211335 | ORIG-1 | TADALAFIL | SUNSHINE LAKE | Approval | |
| TADALAFIL ANDA #211839 | ORIG-1 | TADALAFIL | TORRENT | Approval | |
| TADALAFIL ANDA #212062 | ORIG-1 | TADALAFIL | TORRENT | Approval | |
| DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020255 | SUPPL-20 | DOBUTAMINE HYDROCHLORIDE | BAXTER HLTHCARE | Labeling | Approval |
| DOCETAXEL NDA #201525 | SUPPL-16 | DOCETAXEL | SANDOZ | Labeling | Approval |
| DOCETAXEL NDA #201525 | SUPPL-17 | DOCETAXEL | SANDOZ | Labeling | Approval |
| JATENZO NDA #206089 | ORIG-1 | TESTOSTERONE UNDECANOATE | CLARUS THERAPEUTICS INC | Type 3 - New Dosage Form | Approval |
| EZALLOR NDA #208647 | SUPPL-1 | ROSUVASTATIN CALCIUM | SUN PHARMA GLOBAL | Labeling | Approval |
| ATAZANAVIR; COBICISTAT ANDA #211124 | ORIG-1 | ATAZANAVIR; COBICISTAT | MYLAN PHARMS INC | Tentative Approval | |
| DOXEPIN HYDROCHLORIDE ANDA #211603 | ORIG-1 | DOXEPIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | Approval | |
| TIZANIDINE HYDROCHLORIDE ANDA #212196 | ORIG-1 | TIZANIDINE HYDROCHLORIDE | ALKEM LABS LTD | Approval | |
| INVIRASE NDA #020628 | SUPPL-47 | SAQUINAVIR MESYLATE | HOFFMANN LA ROCHE | Labeling | Approval |
| TRICOR NDA #021203 | SUPPL-9 | FENOFIBRATE | ABBVIE INC | Labeling | Approval |
| LEXIVA NDA #021548 | SUPPL-41 | FOSAMPRENAVIR CALCIUM | VIIV HLTHCARE | Labeling | Approval |
| TRICOR NDA #021656 | SUPPL-29 | FENOFIBRATE | ABBVIE | Labeling | Approval |
| INVIRASE NDA #021785 | SUPPL-23 | SAQUINAVIR MESYLATE | HOFFMANN-LA ROCHE | Labeling | Approval |
| LETAIRIS NDA #022081 | SUPPL-39 | AMBRISENTAN | GILEAD | REMS | Approval |
| LEXIVA NDA #022116 | SUPPL-25 | FOSAMPRENAVIR CALCIUM | VIIV HLTHCARE | Labeling | Approval |
| TRILIPIX NDA #022224 | SUPPL-15 | CHOLINE FENOFIBRATE | ABBVIE | Labeling | Approval |
| EFFIENT NDA #022307 | SUPPL-16 | PRASUGREL HYDROCHLORIDE | ELI LILLY AND CO | Labeling | Approval |
| CIMZIA BLA #125160 | SUPPL-237 | CERTOLIZUMAB PEGOL | UCB INC | Approval | |
| GRANIX BLA #125294 | SUPPL-46 | TBO-FILGRASTIM | SICOR BIOTECH | Approval | |
| AMBRISENTAN ANDA #208252 | ORIG-1 | AMBRISENTAN | WATSON LABS INC | Approval | |
| AMBRISENTAN ANDA #208441 | ORIG-1 | AMBRISENTAN | MYLAN PHARMS INC | Approval | |
| AMBRISENTAN ANDA #210058 | ORIG-1 | AMBRISENTAN | ZYDUS PHARMS | Approval | |
| AMBRISENTAN ANDA #210784 | ORIG-1 | AMBRISENTAN | SUN PHARM | Approval | |
| LEVOCETIRIZINE DIHYDRO-
CHLORIDE ANDA #211983 | ORIG-1 | LEVOCETIRIZINE DIHYDROCHLORIDE | PERRIGO R AND D | Approval | |
| LAMISIL NDA #020539 | SUPPL-33 | TERBINAFINE HYDROCHLORIDE | NOVARTIS | Labeling | Approval |
| ZELNORM NDA #021200 | SUPPL-15 | TEGASEROD MALEATE | US WORLDMEDS LLC | Efficacy | Approval |
| SENSIPAR NDA #021688 | SUPPL-25 | CINACALCET HYDROCHLORIDE | AMGEN | Labeling | Approval |
| SENSIPAR NDA #021688 | SUPPL-26 | CINACALCET HYDROCHLORIDE | AMGEN | Labeling | Approval |
| LAMISIL NDA #022071 | SUPPL-15 | TERBINAFINE HYDROCHLORIDE | NOVARTIS | Labeling | Approval |
| MAVENCLAD NDA #022561 | ORIG-1 | CLADRIBINE | EMD SERONO INC | Type 3 - New Dosage Form | Approval |
| POLYMYXIN B SULFATE ANDA #060716 | SUPPL-26 | POLYMYXIN B SULFATE | WEST-WARD PHARMS INT | Manufacturing (CMC) | Approval |
| VENLAFAXINE HYDROCHLORIDE ANDA #091272 | SUPPL-14 | VENLAFAXINE HYDROCHLORIDE | SUN PHARMA GLOBAL | Labeling | Approval |
| VENLAFAXINE HYDROCHLORIDE ANDA #091272 | SUPPL-15 | VENLAFAXINE HYDROCHLORIDE | SUN PHARMA GLOBAL | Labeling | Approval |
| VENLAFAXINE HYDROCHLORIDE ANDA #091272 | SUPPL-18 | VENLAFAXINE HYDROCHLORIDE | SUN PHARMA GLOBAL | Manufacturing (CMC) | Approval |
| AVACLYR NDA #202408 | ORIG-1 | ACYCLOVIR | FERA PHARMS LLC | Type 3 - New Dosage Form | Approval |
| TUDORZA PRESSAIR NDA #202450 | SUPPL-12 | ACLIDINIUM BROMIDE | ASTRAZENECA PHARMS | Efficacy | Approval |
| TADALAFIL ANDA #205885 | ORIG-1 | TADALAFIL | WATSON LABS INC | Approval | |
| POTASSIUM CHLORIDE ANDA #206630 | ORIG-1 | POTASSIUM CHLORIDE | PII | Approval | |
| RASAGILINE MESYLATE ANDA #207004 | ORIG-1 | RASAGILINE MESYLATE | MICRO LABS | Approval | |
| AZELASTINE HYDROCHLORIDE ANDA #207411 | ORIG-1 | AZELASTINE HYDROCHLORIDE | SOMERSET THERAPS LLC | Approval | |
| DUAKLIR PRESSAIR NDA #210595 | ORIG-1 | ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE DIHYDRATE | ASTRAZENECA PHARMS | Type 4 - New Combination | Approval |
| POTASSIUM CHLORIDE ANDA #210766 | ORIG-1 | POTASSIUM CHLORIDE | PHARM ASSOC | Approval |
