Drugs@FDA: FDA Approved Drug Products

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All Approvals
March 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on June 26, 2019.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
03/01/2019 ROBAXIN
NDA #011011
SUPPL-79 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
03/01/2019 ROBAXIN-750
NDA #011011
SUPPL-79 METHOCARBAMOL AUXILIUM PHARMS LLC Labeling Approval
03/01/2019 TRANSDERM SCOP
NDA #017874
SUPPL-43 SCOPOLAMINE GLAXOSMITHKLINE CON Efficacy Approval
03/01/2019 TRANSDERM SCOP
NDA #017874
SUPPL-44 SCOPOLAMINE GLAXOSMITHKLINE CON Labeling Approval
03/01/2019 ZOCOR
NDA #019766
SUPPL-92 SIMVASTATIN MSD MERCK CO Labeling Approval
03/01/2019 SUPRANE
NDA #020118
SUPPL-22 DESFLURANE BAXTER HLTHCARE Manufacturing (CMC) Approval
03/01/2019 SUPRANE
NDA #020118
SUPPL-23 DESFLURANE BAXTER HLTHCARE Labeling Approval
03/01/2019 CLARINEX
NDA #021165
SUPPL-20 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/01/2019 FLECTOR
NDA #021234
SUPPL-16 DICLOFENAC EPOLAMINE INST BIOCHEM Efficacy Approval
03/01/2019 FLECTOR
NDA #021234
SUPPL-17 DICLOFENAC EPOLAMINE INST BIOCHEM Labeling Approval
03/01/2019 CLARINEX
NDA #021300
SUPPL-17 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/01/2019 CLARINEX
NDA #021312
SUPPL-18 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/01/2019 CLARINEX
NDA #021563
SUPPL-6 DESLORATADINE SCHERING Labeling Approval
03/01/2019 FENOFIBRATE
ANDA #076509
SUPPL-31 FENOFIBRATE IMPAX LABS Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #076706
SUPPL-14 METFORMIN HYDROCHLORIDE APOTEX Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #076706
SUPPL-16 METFORMIN HYDROCHLORIDE APOTEX Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #076864
SUPPL-15 METFORMIN HYDROCHLORIDE TEVA Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #076864
SUPPL-16 METFORMIN HYDROCHLORIDE TEVA Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #077336
SUPPL-12 METFORMIN HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
03/01/2019 METFORMIN HYDROCHLORIDE
ANDA #077336
SUPPL-15 METFORMIN HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
03/01/2019 BUSPIRONE HYDROCHLORIDE
ANDA #204582
SUPPL-1 BUSPIRONE HYDROCHLORIDE HERITAGE PHARMA Labeling Approval
03/01/2019 BUSPIRONE HYDROCHLORIDE
ANDA #204582
SUPPL-2 BUSPIRONE HYDROCHLORIDE HERITAGE PHARMA Manufacturing (CMC) Approval
03/01/2019 PERPHENAZINE
ANDA #205056
ORIG-1 PERPHENAZINE RISING Approval
03/01/2019 ROSUVASTATIN CALCIUM
ANDA #206513
ORIG-1 ROSUVASTATIN CALCIUM ZYDUS PHARMS Approval
03/01/2019 IMATINIB MESYLATE
ANDA #207818
ORIG-1 IMATINIB MESYLATE NATCO PHARMA LTD Approval
03/01/2019 PHENYLEPHRINE HYDROCHLORIDE
NDA #207926
SUPPL-2 PHENYLEPHRINE HYDROCHLORIDE AKORN INC Labeling Approval
03/01/2019 XHANCE
NDA #209022
SUPPL-6 FLUTICASONE PROPIONATE OPTINOSE US INC Manufacturing (CMC) Approval
03/01/2019 DAPSONE
ANDA #209430
ORIG-1 DAPSONE TARO PHARM Approval
03/01/2019 PANTOPRAZOLE SODIUM
ANDA #211368
ORIG-1 PANTOPRAZOLE SODIUM INGENUS PHARMS LLC Approval
03/04/2019 LUPRON DEPOT
NDA #019732
SUPPL-44 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
03/04/2019 LUPRON DEPOT
NDA #020517
SUPPL-42 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
03/04/2019 TELMISARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202544
ORIG-1 HYDROCHLOROTHIAZIDE; TELMISARTAN GLENMARK PHARMS LTD Approval
03/04/2019 DESVENLAFAXINE SUCCINATE
ANDA #204003
SUPPL-6 DESVENLAFAXINE SUCCINATE ALEMBIC PHARMS LTD Labeling Approval
03/04/2019 ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
ANDA #205769
ORIG-1 ALISKIREN HEMIFUMARATE;HYDROCHLOROTHIAZIDE PAR PHARM INC Tentative Approval
03/04/2019 RIVASTIGMINE
ANDA #206318
ORIG-1 RIVASTIGMINE ZYDUS NOVELTECH INC Approval
03/04/2019 NUPLAZID
NDA #207318
SUPPL-6 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
03/04/2019 FULVESTRANT
ANDA #210044
ORIG-1 FULVESTRANT AMNEAL PHARMS CO Approval
03/04/2019 NUPLAZID
NDA #210793
SUPPL-1 PIMAVANSERIN TARTRATE ACADIA PHARMS INC Labeling Approval
03/04/2019 CLOBETASOL PROPIONATE
ANDA #211800
ORIG-1 CLOBETASOL PROPIONATE ALEOR DERMACEUTICALS Approval
03/05/2019 LAMIVUDINE
ANDA #078545
ORIG-1 LAMIVUDINE MYLAN LABS LTD Approval
03/05/2019 ZYKADIA
NDA #205755
SUPPL-16 CERITINIB NOVARTIS PHARMS CORP Labeling Approval
03/05/2019 BEPOTASTINE BESILATE
ANDA #206066
ORIG-1 BEPOTASTINE BESILATE APOTEX INC Approval
03/05/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #209202
ORIG-1 ESOMEPRAZOLE MAGNESIUM ACTAVIS ELIZABETH Approval
03/05/2019 CLONIDINE HYDROCHLORIDE
ANDA #209675
ORIG-1 CLONIDINE HYDROCHLORIDE NOVAST LABS Approval
03/05/2019 PREVYMIS
NDA #209939
SUPPL-3 LETERMOVIR MERCK SHARP DOHME Labeling Approval
03/05/2019 PREVYMIS
NDA #209940
SUPPL-1 LETERMOVIR MERCK SHARP DOHME Labeling Approval
03/05/2019 SPRAVATO
NDA #211243
ORIG-1 ESKETAMINE HYDROCHLORIDE JANSSEN PHARMS Type 2 - New Active Ingredient Approval
03/06/2019 SIMVASTATIN
ANDA #078034
SUPPL-12 SIMVASTATIN BIOCON LIMITED Labeling Approval
03/06/2019 CARVEDILOL
ANDA #078251
SUPPL-18 CARVEDILOL GLENMARK GENERICS Labeling Approval
03/06/2019 TRANEXAMIC ACID
ANDA #201885
SUPPL-6 TRANEXAMIC ACID LUITPOLD Labeling Approval
03/06/2019 BUMETANIDE
ANDA #202900
SUPPL-1 BUMETANIDE ZYDUS PHARMS Labeling Approval
03/06/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #204802
SUPPL-5 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
03/06/2019 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #204802
SUPPL-8 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE MACLEODS PHARMS LTD Labeling Approval
03/06/2019 ATORVASTATIN CALCIUM
ANDA #204991
ORIG-1 ATORVASTATIN CALCIUM LUPIN LTD Approval
03/06/2019 SIVEXTRO
NDA #205435
SUPPL-10 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Efficacy Approval
03/06/2019 SIVEXTRO
NDA #205436
SUPPL-5 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Efficacy Approval
03/06/2019 CALCITRIOL
ANDA #211030
ORIG-1 CALCITRIOL GLAND PHARMA LTD Tentative Approval
03/07/2019 IMODIUM A-D
NDA #019860
SUPPL-33 LOPERAMIDE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
03/07/2019 OPDIVO
BLA #125554
SUPPL-42 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
03/07/2019 ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
ANDA #210899
ORIG-1 ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE LAURUS LABS LTD Tentative Approval
03/08/2019 HALDOL
NDA #015923
SUPPL-95 HALOPERIDOL LACTATE JANSSEN PHARMS Labeling Approval
03/08/2019 HALDOL
NDA #018701
SUPPL-73 HALOPERIDOL DECANOATE JANSSEN PHARMS Labeling Approval
03/08/2019 SPORANOX
NDA #020083
SUPPL-63 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
03/08/2019 SPORANOX
NDA #020657
SUPPL-37 ITRACONAZOLE JANSSEN PHARMS Labeling Approval
03/08/2019 PARSABIV
NDA #208325
SUPPL-2 ETELCALCETIDE KAI PHARMS INC Labeling Approval
03/08/2019 TOFACITINIB
ANDA #209790
ORIG-1 TOFACITINIB SUN PHARM INDS LTD Tentative Approval
03/08/2019 ATENOLOL AND CHLORTHALIDONE
ANDA #210028
ORIG-1 ATENOLOL; CHLORTHALIDONE ZYDUS PHARMS Approval
03/08/2019 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211023
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE WES PHARMA INC Approval
03/08/2019 FOLIC ACID
ANDA #211064
ORIG-1 FOLIC ACID INVATECH PHARMA Approval
03/08/2019 PYRIDOSTIGMINE BROMIDE
ANDA #211694
ORIG-1 PYRIDOSTIGMINE BROMIDE NOVITIUM PHARMA Approval
03/08/2019 TECENTRIQ
BLA #761034
SUPPL-18 ATEZOLIZUMAB GENENTECH INC Approval
03/10/2019 TORSEMIDE
ANDA #076110
SUPPL-6 TORSEMIDE TEVA Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217
SUPPL-2 ENTECAVIR AUROBINDO PHARMA LTD Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217
SUPPL-5 ENTECAVIR AUROBINDO PHARMA LTD Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217
SUPPL-6 ENTECAVIR AUROBINDO PHARMA LTD Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217
SUPPL-7 ENTECAVIR AUROBINDO PHARMA LTD Labeling Approval
03/10/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #206753
SUPPL-2 ASPIRIN; DIPYRIDAMOLE ZYDUS PHARMS Labeling Approval
03/10/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #209048
SUPPL-1 ASPIRIN; DIPYRIDAMOLE DR REDDYS Labeling Approval
03/11/2019 FASLODEX
NDA #021344
SUPPL-37 FULVESTRANT ASTRAZENECA Efficacy Approval
03/11/2019 NOXAFIL
NDA #022003
SUPPL-24 POSACONAZOLE SCHERING Labeling Approval
03/11/2019 PROCHLORPERAZINE EDISYLATE
ANDA #040540
SUPPL-16 PROCHLORPERAZINE EDISYLATE ATHENEX INC Manufacturing (CMC) Approval
03/11/2019 NIKKI
ANDA #201661
SUPPL-1 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
03/11/2019 NIKKI
ANDA #201661
SUPPL-4 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
03/11/2019 NIKKI
ANDA #201661
SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Manufacturing (CMC) Approval
03/11/2019 MAGNESIUM SULFATE
ANDA #202411
SUPPL-2 MAGNESIUM SULFATE HOSPIRA INC Manufacturing (CMC) Approval
03/11/2019 EPTIFIBATIDE
ANDA #204362
ORIG-1 EPTIFIBATIDE USV Approval
03/11/2019 NOXAFIL
NDA #205053
SUPPL-8 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
03/11/2019 NOXAFIL
NDA #205596
SUPPL-7 POSACONAZOLE MERCK SHARP DOHME Labeling Approval
03/11/2019 POTASSIUM CHLORIDE
ANDA #208445
ORIG-1 POTASSIUM CHLORIDE ZYDUS PHARMS Approval
03/11/2019 BRIMONIDINE TARTRATE
ANDA #208992
ORIG-1 BRIMONIDINE TARTRATE SOMERSET THERAPS LLC Approval
03/11/2019 BLEOMYCIN SULFATE
ANDA #209439
ORIG-1 BLEOMYCIN SULFATE CIPLA Approval
03/11/2019 ENZALUTAMIDE
ANDA #209614
ORIG-1 ENZALUTAMIDE ACTAVIS LABS FL INC Tentative Approval
03/11/2019 DALFAMPRIDINE
ANDA #210158
ORIG-1 DALFAMPRIDINE MICRO LABS Approval
03/11/2019 DUPIXENT
BLA #761055
SUPPL-12 DUPILUMAB REGENERON PHARMACEUTICALS Approval
03/11/2019 AIMOVIG
BLA #761077
SUPPL-1 ERENUMAB-AOOE AMGEN INC Approval
03/11/2019 TRAZIMERA
BLA #761081
ORIG-1 TRASTUZUMAB-QYYP PFIZER INC Approval
03/12/2019 VISIPAQUE 270
NDA #020351
SUPPL-48 IODIXANOL GE HEALTHCARE Labeling Approval
03/12/2019 VISIPAQUE 320
NDA #020351
SUPPL-48 IODIXANOL GE HEALTHCARE Labeling Approval
03/12/2019 BIDIL
NDA #020727
SUPPL-10 HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE ARBOR PHARMS LLC Labeling Approval
03/12/2019 VISIPAQUE 270
NDA #020808
SUPPL-28 IODIXANOL GE HEALTHCARE Labeling Approval
03/12/2019 VISIPAQUE 320
NDA #020808
SUPPL-28 IODIXANOL GE HEALTHCARE Labeling Approval
03/12/2019 APRISO
NDA #022301
SUPPL-14 MESALAMINE VALEANT PHARMS INTL Labeling Approval
03/12/2019 VALSARTAN
ANDA #205536
ORIG-1 VALSARTAN ALKEM LABS LTD Approval
03/12/2019 LORATADINE
ANDA #207569
ORIG-1 LORATADINE GUARDIAN DRUG Approval
03/12/2019 ROCKLATAN
NDA #208259
ORIG-1 LATANOPROST; NETARSUDIL DIMESYLATE AERIE PHARMS INC Approval
03/12/2019 TIZANIDINE HYDROCHLORIDE
ANDA #210267
ORIG-1 TIZANIDINE HYDROCHLORIDE RICONPHARMA LLC Approval
03/12/2019 NIFEDIPINE
ANDA #210614
ORIG-1 NIFEDIPINE NOVAST LABS Approval
03/12/2019 TETRACAINE HYDROCHLORIDE
NDA #210821
ORIG-1 TETRACAINE HYDROCHLORIDE BAUSCH Type 5 - New Formulation or New Manufacturer Approval
03/12/2019 ALLOPURINOL
ANDA #211820
ORIG-1 ALLOPURINOL UNICHEM LABS LTD Approval
03/12/2019 DESONIDE
ANDA #212002
ORIG-1 DESONIDE TELIGENT PHARMA INC Approval
03/13/2019 NORDETTE-28
NDA #018782
SUPPL-39 ETHINYL ESTRADIOL; LEVONORGESTREL TEVA BRANDED PHARM Labeling Approval
03/13/2019 FENOGLIDE
NDA #022118
SUPPL-9 FENOFIBRATE SALIX Labeling Approval
03/13/2019 KEMEYA
ANDA #202138
ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL SUN PHARM Approval
03/13/2019 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
ANDA #209476
ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
03/13/2019 METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE
ANDA #209573
ORIG-1 METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE ZYDUS PHARMS USA INC Tentative Approval
03/13/2019 DOCETAXEL
ANDA #209634
SUPPL-2 DOCETAXEL CIPLA Labeling Approval
03/13/2019 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #210622
ORIG-1 CETIRIZINE HYDROCHLORIDE HETERO LABS LTD III Approval
03/13/2019 SOLIFENACIN SUCCINATE
ANDA #211423
ORIG-1 SOLIFENACIN SUCCINATE CSPC OUYI PHARM CO Tentative Approval
03/14/2019 HELIDAC
NDA #050719
SUPPL-22 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE CASPER PHARMA LLC Labeling Approval
03/14/2019 EPTIFIBATIDE
ANDA #204361
ORIG-1 EPTIFIBATIDE USV Approval
03/14/2019 AVYCAZ
NDA #206494
SUPPL-5 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN SALES LLC Efficacy Approval
03/14/2019 AVYCAZ
NDA #206494
SUPPL-6 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN SALES LLC Efficacy Approval
03/14/2019 ENOXAPARIN SODIUM
ANDA #208600
ORIG-1 ENOXAPARIN SODIUM AMPHASTAR PHARMS INC Approval
03/14/2019 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #209252
ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GLENMARK PHARMS Approval
03/15/2019 CLARINEX
NDA #021165
SUPPL-22 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/15/2019 CLARINEX
NDA #021300
SUPPL-19 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/15/2019 CLARINEX
NDA #021312
SUPPL-20 DESLORATADINE MERCK SHARP DOHME Labeling Approval
03/15/2019 CLARINEX-D 12 HOUR
NDA #021313
SUPPL-12 DESLORATADINE; PSEUDOEPHEDRINE SULFATE MERCK SHARP DOHME Labeling Approval
03/15/2019 CLARINEX
NDA #021563
SUPPL-8 DESLORATADINE SCHERING Labeling Approval
03/15/2019 CLARINEX D 24 HOUR
NDA #021605
SUPPL-17 DESLORATADINE; PSEUDOEPHEDRINE SULFATE MERCK SHARP DOHME Labeling Approval
03/15/2019 APTIOM
NDA #022416
SUPPL-11 ESLICARBAZEPINE ACETATE SUNOVION PHARMS INC Efficacy Approval
03/15/2019 DIFICID
NDA #201699
SUPPL-10 FIDAXOMICIN CUBIST PHARMS LLC Labeling Approval
03/15/2019 VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203000
ORIG-1 HYDROCHLOROTHIAZIDE; VALSARTAN ZYDUS PHARMS Approval
03/15/2019 ACYCLOVIR
ANDA #205974
ORIG-1 ACYCLOVIR ZYDUS PHARMS Approval
03/15/2019 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
NDA #210649
ORIG-1 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Type 5 - New Formulation or New Manufacturer Approval
03/15/2019 ALBUTEROL SULFATE
ANDA #210948
ORIG-1 ALBUTEROL SULFATE AIZANT Approval
03/15/2019 AZELAIC ACID
ANDA #211077
ORIG-1 AZELAIC ACID PERRIGO PHARMA INTL Tentative Approval
03/15/2019 AXITINIB
ANDA #211650
ORIG-1 AXITINIB APOTEX INC Tentative Approval
03/18/2019 KYNAMRO
NDA #203568
SUPPL-11 MIPOMERSEN SODIUM KASTLE THERAPS LLC Labeling Approval
03/18/2019 BEPOTASTINE BESILATE
ANDA #206220
ORIG-1 BEPOTASTINE BESILATE MYLAN Approval
03/18/2019 FLUOCINONIDE
ANDA #207554
ORIG-1 FLUOCINONIDE TELIGENT PHARMA INC Approval
03/18/2019 GENVOYA
NDA #207561
SUPPL-23 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
03/18/2019 DIAZEPAM
ANDA #210363
ORIG-1 DIAZEPAM BELOTECA INC Approval
03/18/2019 ZYKADIA
NDA #211225
ORIG-1 CERITINIB NOVARTIS PHARMS CORP Approval
03/18/2019 TECENTRIQ
BLA #761034
SUPPL-19 ATEZOLIZUMAB GENENTECH INC Approval
03/19/2019 ALLOPURINOL
ANDA #077353
SUPPL-6 ALLOPURINOL APOTEX INC Labeling Approval
03/19/2019 AMITRIPTYLINE HYDROCHLORIDE
ANDA #089399
SUPPL-45 AMITRIPTYLINE HYDROCHLORIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
03/19/2019 ERTAPENEM SODIUM
ANDA #207647
ORIG-1 ERTAPENEM SODIUM SAVIOR LIFETEC CORP Approval
03/19/2019 LURASIDONE HYDROCHLORIDE
ANDA #208052
ORIG-1 LURASIDONE HYDROCHLORIDE ZYDUS PHARMS Approval
03/19/2019 GLEOLAN
NDA #208630
SUPPL-4 AMINOLEVULINIC ACID HYDROCHLORIDE NXDC Labeling Approval
03/19/2019 PREGABALIN
ANDA #209664
ORIG-1 PREGABALIN DR REDDYS LABS LTD Tentative Approval
03/19/2019 ZULRESSO
NDA #211371
ORIG-1 BREXANOLONE SAGE THERAPEUTICS Type 1 - New Molecular Entity Approval
03/20/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #204552
ORIG-1 ASPIRIN; DIPYRIDAMOLE LANNETT CO INC Approval
03/20/2019 NAFTIFINE HYDROCHLORIDE
ANDA #206165
ORIG-1 NAFTIFINE HYDROCHLORIDE TOLMAR Approval
03/20/2019 AZELASTINE HYDROCHLORIDE
ANDA #209620
ORIG-1 AZELASTINE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
03/20/2019 FLUOXETINE HYDROCHLORIDE
ANDA #210935
ORIG-1 FLUOXETINE HYDROCHLORIDE SCIEGEN PHARMS INC Approval
03/20/2019 SUNOSI
NDA #211230
ORIG-1 SOLRIAMFETOL JAZZ PHARMA IRELAND LTD Type 1 - New Molecular Entity Approval
03/20/2019 SUNOSI
NDA #211230
ORIG-2 SOLRIAMFETOL JAZZ PHARMA IRELAND LTD Type 1 - New Molecular Entity Approval
03/20/2019 METHYLERGONOVINE MALEATE
ANDA #211455
ORIG-1 METHYLERGONOVINE MALEATE TEVA PHARMS USA Approval
03/20/2019 GLYCOPYRROLATE
ANDA #211705
ORIG-1 GLYCOPYRROLATE CAPLIN Approval
03/20/2019 LIBTAYO
BLA #761097
SUPPL-1 CEMIPLIMAB-RWLC REGENERON PHARMACEUTICALS Approval
03/21/2019 PREZISTA
NDA #021976
SUPPL-53 DARUNAVIR ETHANOLATE JANSSEN PRODS Efficacy Approval
03/21/2019 IBUPROFEN
ANDA #071265
SUPPL-46 IBUPROFEN CONTRACT PHARMACAL Labeling Approval
03/21/2019 IBUPROFEN
ANDA #071265
SUPPL-48 IBUPROFEN CONTRACT PHARMACAL Labeling Approval
03/21/2019 IBUPROFEN
ANDA #071265
SUPPL-49 IBUPROFEN CONTRACT PHARMACAL Labeling Approval
03/21/2019 ORENCIA
BLA #125118
SUPPL-224 ABATACEPT BRISTOL MYERS SQUIBB Approval
03/21/2019 PREZISTA
NDA #202895
SUPPL-24 DARUNAVIR ETHANOLATE JANSSEN PRODS Efficacy Approval
03/21/2019 RIVASTIGMINE
ANDA #207308
SUPPL-1 RIVASTIGMINE AMNEAL PHARMS Labeling Approval
03/21/2019 DOPTELET
NDA #210238
SUPPL-2 AVATROMBOPAG MALEATE AKARX INC Labeling Approval
03/21/2019 LAMIVUDINE
ANDA #211306
ORIG-1 LAMIVUDINE ANNORA Approval
03/21/2019 RENFLEXIS
BLA #761054
SUPPL-4 INFLIXIMAB-ABDA SAMSUNG BIOEPIS CO LTD Approval
03/21/2019 FULPHILA
BLA #761075
SUPPL-1 PEGFILGRASTIM-JMDB MYLAN GMBH Approval
03/22/2019 PHENDIMETRAZINE TARTRATE
NDA #018074
SUPPL-36 PHENDIMETRAZINE TARTRATE VIRTUS PHARMS Labeling Approval
03/22/2019 MOMETASONE FUROATE
ANDA #076788
SUPPL-10 MOMETASONE FUROATE TARO Labeling Approval
03/22/2019 AMLODIPINE BESYLATE
ANDA #078573
SUPPL-17 AMLODIPINE BESYLATE TORRENT PHARMS Labeling Approval
03/22/2019 PROPRANOLOL HYDROCHLORIDE
ANDA #078703
SUPPL-9 PROPRANOLOL HYDROCHLORIDE RP SCHERER Manufacturing (CMC) Approval
03/22/2019 LEVALBUTEROL HYDROCHLORIDE
ANDA #090297
SUPPL-8 LEVALBUTEROL HYDROCHLORIDE TEVA PHARMS USA Manufacturing (CMC) Approval
03/22/2019 PIRMELLA 7/7/7
ANDA #201510
SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Labeling Approval
03/22/2019 PIRMELLA 1/35
ANDA #201512
SUPPL-8 ETHINYL ESTRADIOL; NORETHINDRONE LUPIN LTD Labeling Approval
03/22/2019 BIMATOPROST
ANDA #203604
ORIG-1 BIMATOPROST HI-TECH PHARMACAL Tentative Approval
03/22/2019 RANITIDINE HYDROCHLORIDE
ANDA #205512
SUPPL-8 RANITIDINE HYDROCHLORIDE STRIDES PHARMA Manufacturing (CMC) Approval
03/22/2019 ALISKIREN HEMIFUMARATE
ANDA #206665
ORIG-1 ALISKIREN HEMIFUMARATE ANCHEN PHARMS Approval
03/22/2019 ROFLUMILAST
ANDA #208180
ORIG-1 ROFLUMILAST MICRO LABS Approval
03/22/2019 RHOPRESSA
NDA #208254
SUPPL-3 NETARSUDIL DIMESYLATE AERIE PHARMS INC Labeling Approval
03/22/2019 EZETIMIBE AND SIMVASTATIN
ANDA #208831
SUPPL-1 EZETIMIBE; SIMVASTATIN AMNEAL PHARMS CO Labeling Approval
03/22/2019 BIMATOPROST
ANDA #210126
ORIG-1 BIMATOPROST GLAND PHARMA LTD Approval
03/22/2019 DIMETHYL FUMARATE
ANDA #210460
ORIG-1 DIMETHYL FUMARATE MSN LABORATORIES Tentative Approval
03/22/2019 HYDROXYPROGESTERONE CAPROATE
ANDA #210877
ORIG-1 HYDROXYPROGESTERONE CAPROATE SLAYBACK PHARMA LLC Approval
03/22/2019 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #211944
ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL HETERO LABS LTD Approval
03/22/2019 SILDENAFIL CITRATE
ANDA #212051
ORIG-1 SILDENAFIL CITRATE LUPIN LTD Approval
03/25/2019 TACROLIMUS
ANDA #065461
SUPPL-29 TACROLIMUS SANDOZ Labeling Approval
03/25/2019 TACROLIMUS
ANDA #065461
SUPPL-30 TACROLIMUS SANDOZ Labeling Approval
03/25/2019 TRAZODONE HYDROCHLORIDE
ANDA #071406
SUPPL-6 TRAZODONE HYDROCHLORIDE MYLAN Labeling Approval
03/25/2019 SILDENAFIL CITRATE
ANDA #201171
ORIG-1 SILDENAFIL CITRATE MYLAN Approval
03/25/2019 ARMODAFINIL
ANDA #201514
ORIG-1 ARMODAFINIL APOTEX INC Approval
03/25/2019 AZELASTINE HYDROCHLORIDE
ANDA #204660
SUPPL-1 AZELASTINE HYDROCHLORIDE AMNEAL PHARMS LLC Labeling Approval
03/25/2019 AZACITIDINE
ANDA #207518
SUPPL-4 AZACITIDINE SHILPA MEDICARE Labeling Approval
03/25/2019 IVERMECTIN
ANDA #210019
ORIG-1 IVERMECTIN TEVA PHARMS USA INC Tentative Approval
03/25/2019 DIMETHYL FUMARATE
ANDA #210285
ORIG-1 DIMETHYL FUMARATE SAWAI USA Tentative Approval
03/25/2019 DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
NDA #210796
ORIG-1 DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Type 4 - New Combination Tentative Approval
03/25/2019 LURASIDONE HYDROCHLORIDE
ANDA #212091
ORIG-1 LURASIDONE HYDROCHLORIDE PIRAMAL HLTHCARE UK Tentative Approval
03/26/2019 H.P. ACTHAR GEL
NDA #008372
SUPPL-61 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
03/26/2019 INDOCIN
NDA #016059
SUPPL-100 INDOMETHACIN EGALET Labeling Approval
03/26/2019 INDOCIN
NDA #017814
SUPPL-43 INDOMETHACIN EGALET Labeling Approval
03/26/2019 INDOCIN SR
NDA #018185
SUPPL-57 INDOMETHACIN EGALET Labeling Approval
03/26/2019 INDOCIN
NDA #018332
SUPPL-40 INDOMETHACIN EGALET Labeling Approval
03/26/2019 TAGAMET HB
NDA #020238
SUPPL-23 CIMETIDINE MEDTECH PRODUCTS Labeling Approval
03/26/2019 ERIVEDGE
NDA #203388
SUPPL-14 VISMODEGIB GENENTECH Labeling Approval
03/26/2019 TIVORBEX
NDA #204768
SUPPL-6 INDOMETHACIN EGALET Labeling Approval
03/26/2019 TADALAFIL
ANDA #204809
ORIG-1 TADALAFIL ALEMBIC PHARMS LTD Approval
03/26/2019 ENTECAVIR
ANDA #206226
ORIG-1 ENTECAVIR MYLAN Approval
03/26/2019 TADALAFIL
ANDA #206285
ORIG-1 TADALAFIL AUROBINDO PHARMA LTD Approval
03/26/2019 TADALAFIL
ANDA #206693
ORIG-1 TADALAFIL ZYDUS PHARMS Approval
03/26/2019 TADALAFIL
ANDA #208934
ORIG-1 TADALAFIL SUN PHARM Approval
03/26/2019 TADALAFIL
ANDA #209167
ORIG-1 TADALAFIL ACCORD HLTHCARE Approval
03/26/2019 TADALAFIL
ANDA #209250
ORIG-1 TADALAFIL UNICHEM LABS LTD Approval
03/26/2019 TADALAFIL
ANDA #209539
ORIG-1 TADALAFIL CIPLA Approval
03/26/2019 TADALAFIL
ANDA #209654
ORIG-1 TADALAFIL AJANTA PHARMA LTD Approval
03/26/2019 TADALAFIL
ANDA #209744
ORIG-1 TADALAFIL AMNEAL PHARMS CO Approval
03/26/2019 MAYZENT
NDA #209884
ORIG-1 SIPONIMOD FUMARIC ACID NOVARTIS PHARMS CORP Type 1 - New Molecular Entity Approval
03/26/2019 TADALAFIL
ANDA #209908
ORIG-1 TADALAFIL HETERO LABS LTD III Approval
03/26/2019 TIZANIDINE HYDROCHLORIDE
ANDA #210021
ORIG-1 TIZANIDINE HYDROCHLORIDE CADILA PHARMS LTD Approval
03/26/2019 TADALAFIL
ANDA #210069
ORIG-1 TADALAFIL DR REDDYS LABS LTD Approval
03/26/2019 CEPHALEXIN
ANDA #210221
ORIG-1 CEPHALEXIN ALKEM LABS LTD Approval
03/26/2019 TADALAFIL
ANDA #210420
ORIG-1 TADALAFIL QILU PHARM CO LTD Approval
03/26/2019 TADALAFIL
ANDA #210567
ORIG-1 TADALAFIL LUPIN LTD Approval
03/26/2019 TADALAFIL
ANDA #211335
ORIG-1 TADALAFIL SUNSHINE LAKE Approval
03/26/2019 TADALAFIL
ANDA #211839
ORIG-1 TADALAFIL TORRENT Approval
03/26/2019 TADALAFIL
ANDA #212062
ORIG-1 TADALAFIL TORRENT Approval
03/27/2019 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020255
SUPPL-20 DOBUTAMINE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
03/27/2019 DOCETAXEL
NDA #201525
SUPPL-16 DOCETAXEL SANDOZ Labeling Approval
03/27/2019 DOCETAXEL
NDA #201525
SUPPL-17 DOCETAXEL SANDOZ Labeling Approval
03/27/2019 JATENZO
NDA #206089
ORIG-1 TESTOSTERONE UNDECANOATE CLARUS Type 3 - New Dosage Form Approval
03/27/2019 EZALLOR
NDA #208647
SUPPL-1 ROSUVASTATIN CALCIUM SUN PHARMA GLOBAL Labeling Approval
03/27/2019 ATAZANAVIR; COBICISTAT
ANDA #211124
ORIG-1 ATAZANAVIR;COBICISTAT MYLAN PHARMS INC Tentative Approval
03/27/2019 DOXEPIN HYDROCHLORIDE
ANDA #211603
ORIG-1 DOXEPIN HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
03/27/2019 TIZANIDINE HYDROCHLORIDE
ANDA #212196
ORIG-1 TIZANIDINE HYDROCHLORIDE ALKEM LABS LTD Approval
03/28/2019 INVIRASE
NDA #020628
SUPPL-47 SAQUINAVIR MESYLATE HOFFMANN LA ROCHE Labeling Approval
03/28/2019 TRICOR
NDA #021203
SUPPL-9 FENOFIBRATE ABBVIE INC Labeling Approval
03/28/2019 LEXIVA
NDA #021548
SUPPL-41 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/28/2019 TRICOR
NDA #021656
SUPPL-29 FENOFIBRATE ABBVIE Labeling Approval
03/28/2019 INVIRASE
NDA #021785
SUPPL-23 SAQUINAVIR MESYLATE HOFFMANN-LA ROCHE Labeling Approval
03/28/2019 LETAIRIS
NDA #022081
SUPPL-39 AMBRISENTAN GILEAD REMS Approval
03/28/2019 LEXIVA
NDA #022116
SUPPL-25 FOSAMPRENAVIR CALCIUM VIIV HLTHCARE Labeling Approval
03/28/2019 TRILIPIX
NDA #022224
SUPPL-15 CHOLINE FENOFIBRATE ABBVIE Labeling Approval
03/28/2019 EFFIENT
NDA #022307
SUPPL-16 PRASUGREL HYDROCHLORIDE ELI LILLY AND CO Labeling Approval
03/28/2019 CIMZIA
BLA #125160
SUPPL-237 CERTOLIZUMAB PEGOL UCB INC Approval
03/28/2019 GRANIX
BLA #125294
SUPPL-46 TBO-FILGRASTIM SICOR BIOTECH Approval
03/28/2019 AMBRISENTAN
ANDA #208252
ORIG-1 AMBRISENTAN WATSON LABS INC Approval
03/28/2019 AMBRISENTAN
ANDA #208441
ORIG-1 AMBRISENTAN MYLAN Approval
03/28/2019 AMBRISENTAN
ANDA #210058
ORIG-1 AMBRISENTAN ZYDUS PHARMS Approval
03/28/2019 AMBRISENTAN
ANDA #210784
ORIG-1 AMBRISENTAN SUN PHARM Approval
03/28/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211983
ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE PERRIGO R AND D Approval
03/29/2019 LAMISIL
NDA #020539
SUPPL-33 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
03/29/2019 ZELNORM
NDA #021200
SUPPL-15 TEGASEROD MALEATE US WORLDMEDS LLC Efficacy Approval
03/29/2019 SENSIPAR
NDA #021688
SUPPL-25 CINACALCET HYDROCHLORIDE AMGEN Labeling Approval
03/29/2019 SENSIPAR
NDA #021688
SUPPL-26 CINACALCET HYDROCHLORIDE AMGEN Labeling Approval
03/29/2019 LAMISIL
NDA #022071
SUPPL-15 TERBINAFINE HYDROCHLORIDE NOVARTIS Labeling Approval
03/29/2019 MAVENCLAD
NDA #022561
ORIG-1 CLADRIBINE EMD SERONO INC Type 3 - New Dosage Form Approval
03/29/2019 POLYMYXIN B SULFATE
ANDA #060716
SUPPL-26 POLYMYXIN B SULFATE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
03/29/2019 VENLAFAXINE HYDROCHLORIDE
ANDA #091272
SUPPL-14 VENLAFAXINE HYDROCHLORIDE SUN PHARM Labeling Approval
03/29/2019 VENLAFAXINE HYDROCHLORIDE
ANDA #091272
SUPPL-15 VENLAFAXINE HYDROCHLORIDE SUN PHARM Labeling Approval
03/29/2019 VENLAFAXINE HYDROCHLORIDE
ANDA #091272
SUPPL-18 VENLAFAXINE HYDROCHLORIDE SUN PHARM Manufacturing (CMC) Approval
03/29/2019 AVACLYR
NDA #202408
ORIG-1 ACYCLOVIR FERA PHARMS LLC Type 3 - New Dosage Form Approval
03/29/2019 TUDORZA PRESSAIR
NDA #202450
SUPPL-12 ACLIDINIUM BROMIDE ASTRAZENECA PHARMS Efficacy Approval
03/29/2019 TADALAFIL
ANDA #205885
ORIG-1 TADALAFIL WATSON LABS INC Approval
03/29/2019 POTASSIUM CHLORIDE
ANDA #206630
ORIG-1 POTASSIUM CHLORIDE PII Approval
03/29/2019 RASAGILINE MESYLATE
ANDA #207004
ORIG-1 RASAGILINE MESYLATE MICRO LABS Approval
03/29/2019 AZELASTINE HYDROCHLORIDE
ANDA #207411
ORIG-1 AZELASTINE HYDROCHLORIDE SOMERSET THERAPS LLC Approval
03/29/2019 DUAKLIR PRESSAIR
NDA #210595
ORIG-1 ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE CIRCASSIA Type 4 - New Combination Approval
03/29/2019 POTASSIUM CHLORIDE
ANDA #210766
ORIG-1 POTASSIUM CHLORIDE PHARM ASSOC Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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