U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
March 2019

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on May 08, 2024.

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 BAXTER HLTHCARE CORP Efficacy Approval
03/01/2019 TRANSDERM SCOP
NDA #017874		 SUPPL-44 SCOPOLAMINE BAXTER HLTHCARE CORP Labeling Approval
03/01/2019 ZOCOR
NDA #019766		 SUPPL-92 SIMVASTATIN ORGANON 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 ORGANON Labeling Approval
03/01/2019 FLECTOR
NDA #021234		 SUPPL-16 DICLOFENAC EPOLAMINE IBSA Efficacy Approval
03/01/2019 FLECTOR
NDA #021234		 SUPPL-17 DICLOFENAC EPOLAMINE IBSA 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 ORGANON 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 ZHEJIANG JINGXIN 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 ALCON 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 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 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 PHARMS 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 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 ALEMBIC Approval
03/05/2019 LAMIVUDINE
ANDA #078545		 ORIG-1 LAMIVUDINE MYLAN LABS LTD Approval
03/05/2019 MOXIFLOXACIN HYDROCHLORIDE
NDA #205572		 SUPPL-5 MOXIFLOXACIN HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
03/05/2019 ZYKADIA
NDA #205755		 SUPPL-16 CERITINIB NOVARTIS Labeling Approval
03/05/2019 BEPOTASTINE BESILATE
ANDA #206066		 ORIG-1 BEPOTASTINE BESILATE APOTEX Approval
03/05/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #209202		 ORIG-1 ESOMEPRAZOLE MAGNESIUM P AND L 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 PHARMA Labeling Approval
03/06/2019 CARVEDILOL
ANDA #078251		 SUPPL-18 CARVEDILOL GLENMARK PHARMS LTD Labeling Approval
03/06/2019 TRANEXAMIC ACID
ANDA #201885		 SUPPL-6 TRANEXAMIC ACID AM REGENT 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
03/07/2019 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 ATHEM 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 Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217		 SUPPL-5 ENTECAVIR AUROBINDO PHARMA Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217		 SUPPL-6 ENTECAVIR AUROBINDO PHARMA Labeling Approval
03/10/2019 ENTECAVIR
ANDA #206217		 SUPPL-7 ENTECAVIR AUROBINDO PHARMA 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 SAGENT 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 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 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 AZURITY 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 SALIX 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 ALCON LABS INC New Combination and New Formulation or New Manufacturer Approval
03/12/2019 TIZANIDINE HYDROCHLORIDE
ANDA #210267		 ORIG-1 TIZANIDINE HYDROCHLORIDE NOVAST LABS 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 LOMB IRELAND Type 5 - New Formulation or New Manufacturer Approval
03/12/2019 ALLOPURINOL
ANDA #211820		 ORIG-1 ALLOPURINOL UNICHEM Approval
03/12/2019 DESONIDE
ANDA #212002		 ORIG-1 DESONIDE PAI HOLDINGS PHARM 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 MEITHEAL Labeling Approval
03/13/2019 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #210622		 ORIG-1 CETIRIZINE HYDROCHLORIDE HETERO LABS LTD III 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 Efficacy Approval
03/14/2019 AVYCAZ
NDA #206494		 SUPPL-6 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN 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 ORGANON 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 ORGANON Labeling Approval
03/15/2019 CLARINEX-D 12 HOUR
NDA #021313		 SUPPL-12 DESLORATADINE; PSEUDOEPHEDRINE SULFATE ORGANON LLC 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 ORGANON Labeling Approval
03/15/2019 APTIOM
NDA #022416		 SUPPL-11 ESLICARBAZEPINE ACETATE SUMITOMO PHARMA AM 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 LIFESCIENCES Approval
03/15/2019 ACYCLOVIR
ANDA #205974		 ORIG-1 ACYCLOVIR ZYDUS LIFESCIENCES 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 PAI HOLDINGS PHARM 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 Approval
03/18/2019 ZYKADIA
NDA #211225		 ORIG-1 CERITINIB NOVARTIS Approval
03/18/2019 TECENTRIQ
BLA #761034		 SUPPL-19 ATEZOLIZUMAB GENENTECH INC Approval
03/19/2019 ALLOPURINOL
ANDA #077353		 SUPPL-6 ALLOPURINOL CHARTWELL 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 ZULRESSO
NDA #211371		 ORIG-1 BREXANOLONE SAGE THERAP Type 1 - New Molecular Entity Approval
03/20/2019 ASPIRIN AND DIPYRIDAMOLE
ANDA #204552		 ORIG-1 ASPIRIN; DIPYRIDAMOLE CHARTWELL MOLECULAR Approval
03/20/2019 NAFTIFINE HYDROCHLORIDE
ANDA #206165		 ORIG-1 NAFTIFINE HYDROCHLORIDE AMNEAL Approval
03/20/2019 AZELASTINE HYDROCHLORIDE
ANDA #209620		 ORIG-1 AZELASTINE HYDROCHLORIDE ALEMBIC 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 HYDROCHLORIDE AXSOME MALTA Type 1 - New Molecular Entity Approval
03/20/2019 SUNOSI
NDA #211230		 ORIG-2 SOLRIAMFETOL HYDROCHLORIDE AXSOME MALTA Efficacy 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 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 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 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 ADARE PHARMS INC 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 MESYLATE ALCON LABS 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 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #211944		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL HETERO LABS Approval
03/22/2019 SILDENAFIL CITRATE
ANDA #212051		 ORIG-1 SILDENAFIL CITRATE CHARTWELL RX 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 COREPHARMA Approval
03/25/2019 AZELASTINE HYDROCHLORIDE
ANDA #204660		 SUPPL-1 AZELASTINE HYDROCHLORIDE AMNEAL Labeling Approval
03/25/2019 AZACITIDINE
ANDA #207518		 SUPPL-4 AZACITIDINE SHILPA MEDICARE Labeling 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
03/26/2019 ACTHAR GEL
NDA #008372		 SUPPL-61 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
03/26/2019 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-61 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
03/26/2019 INDOCIN
NDA #016059		 SUPPL-100 INDOMETHACIN ZYLA LIFE SCIENCES Labeling Approval
03/26/2019 INDOCIN
NDA #017814		 SUPPL-43 INDOMETHACIN ZYLA LIFE SCIENCES Labeling Approval
03/26/2019 INDOCIN SR
NDA #018185		 SUPPL-57 INDOMETHACIN ZYLA Labeling Approval
03/26/2019 INDOCIN
NDA #018332		 SUPPL-40 INDOMETHACIN ZYLA 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 GENUS Labeling Approval
03/26/2019 TADALAFIL
ANDA #204809		 ORIG-1 TADALAFIL ALEMBIC Approval
03/26/2019 ENTECAVIR
ANDA #206226		 ORIG-1 ENTECAVIR RISING 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 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 NOVARTIS 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 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 HAINAN Approval
03/26/2019 TADALAFIL
ANDA #210567		 ORIG-1 TADALAFIL LUPIN LTD Approval
03/26/2019 TADALAFIL
ANDA #211335		 ORIG-1 TADALAFIL SUNSHINE 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 TOLMAR Type 3 - New Dosage Form Approval
03/27/2019 EZALLOR SPRINKLE
NDA #208647		 SUPPL-1 ROSUVASTATIN CALCIUM SUN PHARM 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 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 COSETTE 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 ALFASIGMA 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 HIKMA 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 COVIS 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 STRIDES PHARMA 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 COVIS Type 4 - New Combination Approval
03/29/2019 POTASSIUM CHLORIDE
ANDA #210766		 ORIG-1 POTASSIUM CHLORIDE PHARM ASSOC Approval
Back to Top