Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

All Approvals
July 2017

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 November 18, 2017.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/03/2017 CYTOVENE
NDA #019661
SUPPL-36 GANCICLOVIR SODIUM ROCHE PALO Labeling Approval
07/03/2017 MUCINEX
NDA #021282
SUPPL-48 GUAIFENESIN RECKITT BENCKISER Manufacturing (CMC) Approval
07/03/2017 QUETIAPINE FUMARATE
ANDA #202674
SUPPL-5 QUETIAPINE FUMARATE UNICHEM LABS LTD Manufacturing (CMC) Approval
07/03/2017 OMEPRAZOLE
ANDA #203481
ORIG-1 OMEPRAZOLE BRECKENRIDGE PHARM Approval
07/03/2017 METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
ANDA #208535
ORIG-1 METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE ZYDUS PHARMS USA INC Tentative Approval
07/03/2017 EPHEDRINE SULFATE
NDA #208609
SUPPL-1 EPHEDRINE SULFATE AKORN INC Manufacturing (CMC) Approval
07/05/2017 PROSTIN E2
NDA #017810
SUPPL-19 DINOPROSTONE PHARMACIA AND UPJOHN Labeling Approval
07/05/2017 PREPIDIL
NDA #019617
SUPPL-17 DINOPROSTONE PHARMACIA AND UPJOHN Labeling Approval
07/05/2017 PROMACTA
NDA #022291
SUPPL-18 ELTROMBOPAG OLAMINE NOVARTIS PHARMS CORP Labeling Approval
07/05/2017 TALTZ
BLA #125521
SUPPL-3 IXEKIZUMAB ELI LILLY AND CO Approval
07/05/2017 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202731
ORIG-3 DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA PHARMS USA Approval
07/05/2017 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #203614
ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Approval
07/05/2017 PROMACTA
NDA #207027
SUPPL-3 ELTROMBOPAG OLAMINE NOVARTIS PHARMS CORP Labeling Approval
07/05/2017 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #207807
ORIG-1 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL GLENMARK PHARMS LTD Approval
07/05/2017 OMEPRAZOLE
NDA #209400
ORIG-1 OMEPRAZOLE DEXCEL PHARMA Type 8 - Partial Rx to OTC Switch Approval
07/06/2017 PEDIATRIC ADVIL
NDA #020812
SUPPL-24 IBUPROFEN PFIZER Labeling Approval
07/06/2017 PROTONIX
NDA #020987
SUPPL-53 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
07/06/2017 PROTONIX IV
NDA #020988
SUPPL-59 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
07/06/2017 PROTONIX
NDA #022020
SUPPL-15 PANTOPRAZOLE SODIUM WYETH PHARMS INC Labeling Approval
07/06/2017 VIMOVO
NDA #022511
SUPPL-19 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON PHARMA USA Efficacy Approval
07/06/2017 TOPOTECAN HYDROCHLORIDE
ANDA #204406
ORIG-1 TOPOTECAN HYDROCHLORIDE ACCORD HLTHCARE Approval
07/06/2017 BIVALIRUDIN
ANDA #204876
ORIG-1 BIVALIRUDIN APOTEX INC Approval
07/06/2017 AZITHROMYCIN
ANDA #208250
ORIG-1 AZITHROMYCIN CSPC OUYI PHARM CO Tentative Approval
07/06/2017 MORPHINE SULFATE
ANDA #208809
ORIG-1 MORPHINE SULFATE HI-TECH PHARMACAL Approval
07/07/2017 RECLAST
NDA #021817
SUPPL-27 ZOLEDRONIC ACID NOVARTIS Labeling Approval
07/07/2017 PRAVASTATIN SODIUM
ANDA #076341
SUPPL-19 PRAVASTATIN SODIUM APOTEX INC Labeling Approval
07/07/2017 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #079198
SUPPL-5 OCTREOTIDE ACETATE MYLAN INSTITUTIONAL Labeling Approval
07/07/2017 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #079198
SUPPL-6 OCTREOTIDE ACETATE MYLAN INSTITUTIONAL Labeling Approval
07/07/2017 FLUCYTOSINE
ANDA #204652
ORIG-1 FLUCYTOSINE NOVEL LABS INC Approval
07/07/2017 TRAVOPROST
ANDA #205050
ORIG-1 TRAVOPROST MYLAN PHARMS INC Approval
07/07/2017 BUSULFAN
ANDA #205106
ORIG-1 BUSULFAN SANDOZ INC Approval
07/07/2017 TETRABENAZINE
ANDA #206686
ORIG-1 TETRABENAZINE ACTAVIS LABS FL INC Approval
07/07/2017 LINEZOLID
ANDA #207001
ORIG-1 LINEZOLID HQ SPCLT PHARMA Approval
07/07/2017 DABIGATRAN ETEXILATE
ANDA #208046
ORIG-1 DABIGATRAN ETEXILATE ALEMBIC PHARMS LTD Tentative Approval
07/07/2017 LURASIDONE HYDROCHLORIDE
ANDA #208052
ORIG-1 LURASIDONE HYDROCHLORIDE ZYDUS PHARMS USA Tentative Approval
07/07/2017 LIQUID E-Z-PAQUE
NDA #208143
SUPPL-4 BARIUM SULFATE BRACCO Efficacy Approval
07/07/2017 READI-CAT 2
NDA #208143
SUPPL-4 BARIUM SULFATE BRACCO Efficacy Approval
07/07/2017 READI-CAT 2 SMOOTHIES
NDA #208143
SUPPL-4 BARIUM SULFATE BRACCO Efficacy Approval
07/07/2017 TAGITOL V
NDA #208143
SUPPL-4 BARIUM SULFATE BRACCO Efficacy Approval
07/07/2017 VARIBAR NECTAR
NDA #208143
SUPPL-4 BARIUM SULFATE BRACCO Efficacy Approval
07/07/2017 ENDARI
NDA #208587
ORIG-1 L-GLUTAMINE EMMAUS MEDCL Type 5 - New Formulation or New Manufacturer Approval
07/07/2017 DOXAZOSIN MESYLATE
ANDA #208719
ORIG-1 DOXAZOSIN MESYLATE ZYDUS PHARMS USA INC Approval
07/10/2017 AVALIDE
NDA #020758
SUPPL-72 HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US Labeling Approval
07/10/2017 PLAVIX
NDA #020839
SUPPL-67 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
07/10/2017 XYZAL
NDA #022064
SUPPL-33 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI-AVENTIS US Labeling Approval
07/10/2017 XYZAL
NDA #022157
SUPPL-16 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI-AVENTIS US Labeling Approval
07/10/2017 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #090254
SUPPL-20 CETIRIZINE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
07/10/2017 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #090254
SUPPL-20 CETIRIZINE HYDROCHLORIDE PERRIGO R AND D Labeling Approval
07/10/2017 OCTREOTIDE ACETATE (PRESERVATIVE FREE)
ANDA #090834
SUPPL-2 OCTREOTIDE ACETATE SAGENT PHARMS Labeling Approval
07/10/2017 MEMANTINE HYDROCHLORIDE
ANDA #090961
ORIG-1 MEMANTINE HYDROCHLORIDE ZYDUS PHARMS USA INC Approval
07/10/2017 OCTREOTIDE ACETATE
ANDA #091041
SUPPL-3 OCTREOTIDE ACETATE SAGENT PHARMS Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045
SUPPL-2 DULOXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045
SUPPL-5 DULOXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045
SUPPL-6 DULOXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045
SUPPL-9 DULOXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045
SUPPL-10 DULOXETINE HYDROCHLORIDE APOTEX INC Labeling Approval
07/10/2017 AZITHROMYCIN
ANDA #208249
ORIG-1 AZITHROMYCIN CSPC OUYI PHARM CO Tentative Approval
07/11/2017 LUPRON
NDA #019010
SUPPL-39 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
07/11/2017 CEFUROXIME AXETIL
ANDA #065069
SUPPL-14 CEFUROXIME AXETIL APOTEX Labeling Approval
07/11/2017 PRAVASTATIN SODIUM
ANDA #077917
SUPPL-17 PRAVASTATIN SODIUM LUPIN PHARMS Labeling Approval
07/11/2017 ENBREL
BLA #103795
SUPPL-5551 ETANERCEPT IMMUNEX Approval
07/11/2017 BLINCYTO
BLA #125557
SUPPL-8 BLINATUMOMAB AMGEN Approval
07/11/2017 ULTACAN FORTE
ANDA #201750
ORIG-1 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HANSAMED INC Approval
07/11/2017 ULTACAN
ANDA #201751
ORIG-1 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HANSAMED INC Approval
07/11/2017 ADAPALENE
ANDA #204593
SUPPL-1 ADAPALENE CALL INC Labeling Approval
07/11/2017 FINGOLIMOD
ANDA #207994
ORIG-1 FINGOLIMOD ZYDUS PHARMS USA INC Tentative Approval
07/11/2017 VILAZODONE HYDROCHLORIDE
ANDA #208209
ORIG-1 VILAZODONE HYDROCHLORIDE ACCORD HLTHCARE INC Tentative Approval
07/12/2017 PERTZYE
NDA #022175
SUPPL-4 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) DIGESTIVE CARE INC Labeling Approval
07/12/2017 VANCOMYCIN HYDROCHLORIDE
ANDA #062663
SUPPL-83 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
07/12/2017 VANCOMYCIN HYDROCHLORIDE
ANDA #062663
SUPPL-85 VANCOMYCIN HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
07/12/2017 VANCOCIN HYDROCHLORIDE
ANDA #062812
SUPPL-30 VANCOMYCIN HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/12/2017 VANCOCIN HYDROCHLORIDE
ANDA #062812
SUPPL-31 VANCOMYCIN HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/12/2017 VANCOCIN HYDROCHLORIDE
ANDA #062812
SUPPL-32 VANCOMYCIN HYDROCHLORIDE ANI PHARMS INC Labeling Approval
07/12/2017 FLUOXETINE HYDROCHLORIDE
ANDA #075658
SUPPL-29 FLUOXETINE HYDROCHLORIDE MALLINCKRODT Labeling Approval
07/12/2017 VARDENAFIL HYDROCHLORIDE
ANDA #203689
ORIG-1 VARDENAFIL HYDROCHLORIDE WATSON LABS TEVA Tentative Approval
07/12/2017 TESTOSTERONE
ANDA #205781
ORIG-1 TESTOSTERONE PERRIGO UK FINCO Approval
07/12/2017 PRASUGREL
ANDA #205927
ORIG-1 PRASUGREL HYDROCHLORIDE MYLAN PHARMS INC Approval
07/13/2017 ARALEN
NDA #006002
SUPPL-44 CHLOROQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
07/13/2017 ARALEN HYDROCHLORIDE
NDA #006002
SUPPL-44 CHLOROQUINE HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
07/13/2017 FEMARA
NDA #020726
SUPPL-33 LETROZOLE NOVARTIS PHARMS Labeling Approval
07/13/2017 ZYVOX
NDA #021130
SUPPL-34 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
07/13/2017 ZYVOX
NDA #021131
SUPPL-28 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
07/13/2017 ZYVOX
NDA #021132
SUPPL-33 LINEZOLID PHARMACIA AND UPJOHN Labeling Approval
07/13/2017 AXIRON
NDA #022504
SUPPL-16 TESTOSTERONE ELI LILLY AND CO Labeling Approval
07/13/2017 LEVOFLOXACIN
ANDA #076826
SUPPL-1 LEVOFLOXACIN WATSON LABS TEVA Labeling Approval
07/13/2017 CYPROHEPTADINE HYDROCHLORIDE
ANDA #203191
ORIG-1 CYPROHEPTADINE HYDROCHLORIDE SILARX PHARMS INC Approval
07/13/2017 EPLERENONE
ANDA #206922
ORIG-1 EPLERENONE ACCORD HLTHCARE Approval
07/13/2017 TREMFYA
BLA #761061
ORIG-1 GUSELKUMAB JANSSEN BIOTECH Approval
07/14/2017 FUROSEMIDE
NDA #018823
SUPPL-44 FUROSEMIDE WEST-WARD PHARMS INT Labeling Approval
07/14/2017 EMSAM
NDA #021336
SUPPL-14 SELEGILINE SOMERSET Labeling Approval
07/14/2017 NALLPEN IN PLASTIC CONTAINER
NDA #050655
SUPPL-25 NAFCILLIN SODIUM BAXTER HLTHCARE Labeling Approval
07/14/2017 PAROXETINE HYDROCHLORIDE
ANDA #078194
SUPPL-12 PAROXETINE HYDROCHLORIDE SUN PHARM INDS INC Manufacturing (CMC) Approval
07/14/2017 PAROXETINE HYDROCHLORIDE
ANDA #078194
SUPPL-13 PAROXETINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/14/2017 PAROXETINE HYDROCHLORIDE
ANDA #078194
SUPPL-14 PAROXETINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
07/14/2017 ARMODAFINIL
ANDA #200751
SUPPL-2 ARMODAFINIL LUPIN LTD Labeling Approval
07/14/2017 ARMODAFINIL
ANDA #200751
SUPPL-3 ARMODAFINIL LUPIN LTD Manufacturing (CMC) Approval
07/14/2017 XULANE
ANDA #200910
SUPPL-1 ETHINYL ESTRADIOL; NORELGESTROMIN MYLAN TECHNOLOGIES Labeling Approval
07/14/2017 XULANE
ANDA #200910
SUPPL-3 ETHINYL ESTRADIOL; NORELGESTROMIN MYLAN TECHNOLOGIES Labeling Approval
07/14/2017 PHENTOLAMINE MESYLATE
ANDA #207686
ORIG-1 PHENTOLAMINE MESYLATE PRECISION DOSE INC Approval
07/14/2017 ZYPITAMAG
NDA #208379
ORIG-1 PITAVASTATIN MAGNESIUM ZYDUS PHARMS USA INC Type 2 - New Active Ingredient Approval
07/14/2017 BEVYXXA
NDA #208383
SUPPL-1 BETRIXABAN PORTOLA PHARMS INC Labeling Approval
07/14/2017 METHYLPHENIDATE HYDROCHLORIDE
ANDA #208607
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE IMPAX LABS INC Approval
07/17/2017 MIDOZALAM HYDROCHLORIDE
ANDA #090316
SUPPL-9 MIDAZOLAM HYDROCHLORIDE SAGENT STRIDES Labeling Approval
07/17/2017 DEXAMETHASONE
ANDA #201270
ORIG-1 DEXAMETHASONE LARKEN LABS INC Approval
07/17/2017 FLUOCINOLONE ACETONIDE
ANDA #202849
ORIG-1 FLUOCINOLONE ACETONIDE PERRIGO ISRAEL Approval
07/17/2017 AMIFOSTINE
ANDA #204363
ORIG-1 AMIFOSTINE MYLAN LABS LTD Approval
07/17/2017 TRANEXAMIC ACID
ANDA #205228
ORIG-1 TRANEXAMIC ACID ZYDUS PHARMS USA INC Approval
07/17/2017 LIDOCAINE
ANDA #205318
SUPPL-1 LIDOCAINE TELIGENT PHARMA INC Manufacturing (CMC) Approval
07/17/2017 CHOLINE C-11
ANDA #205690
SUPPL-2 CHOLINE C-11 UNIV TX MD ANDERSON Manufacturing (CMC) Approval
07/17/2017 AMLODIPINE AND OLMESARTAN MEDOXOMIL
ANDA #207073
ORIG-1 AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL ALEMBIC PHARMS LTD Approval
07/17/2017 SEVELAMER CARBONATE
ANDA #207179
ORIG-1 SEVELAMER CARBONATE AUROBINDO PHARMA LTD Approval
07/17/2017 NERLYNX
NDA #208051
ORIG-1 NERATINIB MALEATE PUMA BIOTECH Type 1 - New Molecular Entity Approval
07/18/2017 BLEPHAMIDE
NDA #012813
SUPPL-62 PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM ALLERGAN Labeling Approval
07/18/2017 CHIRHOSTIM
NDA #021256
SUPPL-13 SECRETIN SYNTHETIC HUMAN CHIRHOCLIN Labeling Approval
07/18/2017 RESTASIS
NDA #050790
SUPPL-27 CYCLOSPORINE ALLERGAN Labeling Approval
07/18/2017 RESTASIS MULTIDOSE
NDA #050790
SUPPL-27 CYCLOSPORINE ALLERGAN Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065126
SUPPL-2 CEFUROXIME AXETIL SANDOZ Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065135
SUPPL-20 CEFUROXIME AXETIL LUPIN Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065166
SUPPL-2 CEFUROXIME AXETIL WOCKHARDT Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065308
SUPPL-11 CEFUROXIME AXETIL AUROBINDO PHARMA LTD Labeling Approval
07/18/2017 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #203291
ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL PII Approval
07/18/2017 METHOCARBAMOL
ANDA #205404
ORIG-1 METHOCARBAMOL SAGENT PHARMS Approval
07/18/2017 VOSEVI
NDA #209195
ORIG-1 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR GILEAD SCIENCES INC Type 1 - New Molecular Entity and Type 4 - New Combination Approval
07/19/2017 FLOVENT DISKUS 100
NDA #020833
SUPPL-33 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
07/19/2017 FLOVENT DISKUS 250
NDA #020833
SUPPL-33 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
07/19/2017 FLOVENT DISKUS 50
NDA #020833
SUPPL-33 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
07/19/2017 FLOVENT HFA
NDA #021433
SUPPL-33 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
07/19/2017 AKPENTOLATE
ANDA #040164
SUPPL-8 CYCLOPENTOLATE HYDROCHLORIDE AKORN Labeling Approval
07/19/2017 AKPENTOLATE
ANDA #040165
SUPPL-5 CYCLOPENTOLATE HYDROCHLORIDE AKORN Labeling Approval
07/19/2017 MINOCIN
NDA #050649
SUPPL-27 MINOCYCLINE HYDROCHLORIDE PRECISION DERMAT Labeling Approval
07/19/2017 EPIRUBICIN HYDROCHLORIDE
ANDA #065289
SUPPL-5 EPIRUBICIN HYDROCHLORIDE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
07/19/2017 OGESTREL 0.5/50-21
ANDA #075406
SUPPL-23 ETHINYL ESTRADIOL; NORGESTREL WATSON LABS Labeling Approval
07/19/2017 OGESTREL 0.5/50-28
ANDA #075406
SUPPL-23 ETHINYL ESTRADIOL; NORGESTREL WATSON LABS Labeling Approval
07/19/2017 CANDESARTAN CILEXETIL
ANDA #203813
SUPPL-1 CANDESARTAN CILEXETIL MACLEODS PHARMS LTD Manufacturing (CMC) Approval
07/19/2017 ZYKADIA
NDA #205755
SUPPL-12 CERITINIB NOVARTIS PHARMS CORP Labeling Approval
07/19/2017 INDOMETHACIN SODIUM
ANDA #206561
ORIG-1 INDOMETHACIN SODIUM NAVINTA LLC Approval
07/19/2017 ERYTHROMYCIN
ANDA #208154
ORIG-1 ERYTHROMYCIN TELIGENT PHARMA INC Approval
07/19/2017 LUSDUNA
NDA #208722
ORIG-1 INSULIN GLARGINE MERCK SHARP DOHME Type 5 - New Formulation or New Manufacturer Tentative Approval
07/20/2017 BENLYSTA
BLA #761043
ORIG-1 BELIMUMAB GLAXOSMITHKLINE LLC Approval
07/21/2017 VASOTEC
NDA #018998
SUPPL-82 ENALAPRIL MALEATE VALEANT PHARMS NORTH Labeling Approval
07/21/2017 VASERETIC
NDA #019221
SUPPL-47 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE VALEANT INTL Labeling Approval
07/21/2017 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019615
SUPPL-24 DOPAMINE HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
07/21/2017 ZESTRIL
NDA #019777
SUPPL-76 LISINOPRIL ALVOGEN MALTA Labeling Approval
07/21/2017 ZESTORETIC
NDA #019888
SUPPL-67 HYDROCHLOROTHIAZIDE; LISINOPRIL ALVOGEN MALTA Labeling Approval
07/21/2017 LOTREL
NDA #020364
SUPPL-65 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE NOVARTIS Labeling Approval
07/21/2017 TAZORAC
NDA #020600
SUPPL-9 TAZAROTENE ALLERGAN Labeling Approval
07/21/2017 AVAGE
NDA #021184
SUPPL-9 TAZAROTENE ALLERGAN Labeling Approval
07/21/2017 TAZORAC
NDA #021184
SUPPL-9 TAZAROTENE ALLERGAN Labeling Approval
07/21/2017 ADVIL PM
NDA #021394
SUPPL-23 DIPHENHYDRAMINE CITRATE; IBUPROFEN PFIZER Labeling Approval
07/21/2017 LETAIRIS
NDA #022081
SUPPL-37 AMBRISENTAN GILEAD REMS Approval
07/21/2017 VECURONIUM BROMIDE
ANDA #074334
SUPPL-37 VECURONIUM BROMIDE WATSON LABS Labeling Approval
07/21/2017 YERVOY
BLA #125377
SUPPL-87 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
07/21/2017 XALKORI
NDA #202570
SUPPL-21 CRIZOTINIB PF PRISM CV Labeling Approval
07/21/2017 MESALAMINE
ANDA #203286
ORIG-1 MESALAMINE ZYDUS PHARMS USA INC Approval
07/21/2017 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #204832
ORIG-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM UNICHEM LABS LTD Approval
07/21/2017 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #205291
ORIG-1 CETIRIZINE HYDROCHLORIDE STRIDES PHARMA Approval
07/21/2017 FLUOCINONIDE
ANDA #206003
ORIG-1 FLUOCINONIDE NOVEL LABS INC Approval
07/21/2017 SODIUM CHLORIDE 0.9%
ANDA #206171
ORIG-1 SODIUM CHLORIDE SPECTRA MDCL DEVICES Approval
07/21/2017 ESTRADIOL
ANDA #206388
ORIG-1 ESTRADIOL TEVA PHARMS USA Approval
07/21/2017 ALBUTEROL SULFATE
ANDA #207857
ORIG-1 ALBUTEROL SULFATE SUN PHARMA GLOBAL Approval
07/21/2017 NALTREXONE HYDROCHLORIDE
ANDA #207905
ORIG-1 NALTREXONE HYDROCHLORIDE APOTEX INC Approval
07/21/2017 UPTRAVI
NDA #207947
SUPPL-1 SELEXIPAG ACTELION PHARMS LTD Labeling Approval
07/21/2017 ERLOTINIB
ANDA #208396
ORIG-1 ERLOTINIB APOTEX INC Tentative Approval
07/21/2017 ETHACRYNIC ACID
ANDA #208501
ORIG-1 ETHACRYNIC ACID PAR PHARM INC Approval
07/21/2017 METHOCARBAMOL
ANDA #208507
ORIG-1 METHOCARBAMOL BEXIMCO PHARMS USA Approval
07/21/2017 OXYCODONE HYDROCHLORIDE
ANDA #208593
ORIG-1 OXYCODONE HYDROCHLORIDE ABHAI LLC Approval
07/23/2017 HABITROL
NDA #020076
SUPPL-45 NICOTINE DR REDDYS LABS SA Labeling Approval
07/24/2017 CLINDAMYCIN HYDROCHLORIDE
ANDA #065242
SUPPL-21 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
07/24/2017 CLINDAMYCIN HYDROCHLORIDE
ANDA #065243
SUPPL-17 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
07/24/2017 CLINDAMYCIN HYDROCLHORIDE
ANDA #065243
SUPPL-17 CLINDAMYCIN HYDROCHLORIDE LANNETT Labeling Approval
07/24/2017 LEVORA 0.15/30-28
ANDA #073594
SUPPL-25 ETHINYL ESTRADIOL; LEVONORGESTREL MAYNE PHARMA Labeling Approval
07/24/2017 LOVASTATIN
ANDA #075935
SUPPL-6 LOVASTATIN MYLAN Labeling Approval
07/24/2017 CARBOPLATIN
ANDA #076517
SUPPL-19 CARBOPLATIN HOSPIRA Manufacturing (CMC) Approval
07/24/2017 CARBOPLATIN
ANDA #077059
SUPPL-19 CARBOPLATIN HOSPIRA Manufacturing (CMC) Approval
07/24/2017 MESALAMINE
ANDA #202065
ORIG-1 MESALAMINE SANDOZ INC Tentative Approval
07/24/2017 ELIFEMME
ANDA #202507
SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL LABS LEON FARMA Labeling Approval
07/24/2017 XTANDI
NDA #203415
SUPPL-11 ENZALUTAMIDE ASTELLAS Efficacy Approval
07/24/2017 DESONIDE
ANDA #209729
ORIG-1 DESONIDE GLENMARK PHARMS Approval
07/25/2017 INVOKANA
NDA #204042
SUPPL-26 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
07/25/2017 INVOKAMET
NDA #204353
SUPPL-23 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
07/25/2017 INVOKAMET XR
NDA #205879
SUPPL-5 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
07/25/2017 LURASIDONE HYDROCHLORIDE
ANDA #208060
ORIG-1 LURASIDONE HYDROCHLORIDE TEVA PHARMS USA Tentative Approval
07/25/2017 TELMISARTAN
ANDA #208605
ORIG-1 TELMISARTAN CADILA PHARMS LTD Approval
07/26/2017 CIPRO
NDA #019537
SUPPL-87 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
07/26/2017 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857
SUPPL-66 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
07/26/2017 CIPRO
NDA #020780
SUPPL-44 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
07/26/2017 CIPRO XR
NDA #021473
SUPPL-38 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
07/26/2017 VICTOZA
NDA #022341
SUPPL-29 LIRAGLUTIDE RECOMBINANT NOVO NORDISK INC REMS Approval
07/26/2017 VIBRAMYCIN
NDA #050006
SUPPL-89 DOXYCYCLINE PFIZER Labeling Approval
07/26/2017 VIBRAMYCIN
NDA #050007
SUPPL-32 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
07/26/2017 VIBRAMYCIN
NDA #050442
SUPPL-20 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
07/26/2017 VIBRAMYCIN
NDA #050480
SUPPL-56 DOXYCYCLINE CALCIUM PFIZER Labeling Approval
07/26/2017 VIBRA-TABS
NDA #050533
SUPPL-45 DOXYCYCLINE HYCLATE PFIZER Labeling Approval
07/26/2017 QNASL
NDA #202813
SUPPL-11 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Labeling Approval
07/26/2017 FYCOMPA
NDA #202834
SUPPL-12 PERAMPANEL EISAI INC Efficacy Approval
07/26/2017 OLOPATADINE HYDROCHLORIDE
ANDA #206046
ORIG-1 OLOPATADINE HYDROCHLORIDE CIPLA LTD Approval
07/26/2017 NALOXONE HYDROCHLORIDE
ANDA #207634
ORIG-1 NALOXONE HYDROCHLORIDE SOMERSET THERAPS LLC Approval
07/26/2017 FYCOMPA
NDA #208277
SUPPL-1 PERAMPANEL EISAI INC Efficacy Approval
07/26/2017 EXEMESTANE
ANDA #209208
ORIG-1 EXEMESTANE UPSHER-SMITH LABS Approval
07/26/2017 NITYR
NDA #209449
ORIG-1 NITISINONE CYCLE PHARMS LTD Type 5 - New Formulation or New Manufacturer Approval
07/27/2017 ROWASA
NDA #019618
SUPPL-23 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
07/27/2017 SFROWASA
NDA #019618
SUPPL-23 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
07/27/2017 ASACOL
NDA #019651
SUPPL-27 MESALAMINE APIL Labeling Approval
07/27/2017 PENTASA
NDA #020049
SUPPL-30 MESALAMINE SHIRE Labeling Approval
07/27/2017 ULTRAVIST 150
NDA #020220
SUPPL-43 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/27/2017 ULTRAVIST 240
NDA #020220
SUPPL-43 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/27/2017 ULTRAVIST 300
NDA #020220
SUPPL-43 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/27/2017 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220
SUPPL-43 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/27/2017 ULTRAVIST 370
NDA #020220
SUPPL-43 IOPROMIDE BAYER HLTHCARE Labeling Approval
07/27/2017 CANASA
NDA #021252
SUPPL-23 MESALAMINE FOREST LABS LLC Labeling Approval
07/27/2017 ASACOL HD
NDA #021830
SUPPL-11 MESALAMINE APIL Labeling Approval
07/27/2017 LIALDA
NDA #022000
SUPPL-16 MESALAMINE SHIRE Labeling Approval
07/27/2017 APRISO
NDA #022301
SUPPL-9 MESALAMINE VALEANT PHARMS INTL Labeling Approval
07/27/2017 KEYTRUDA
BLA #125514
SUPPL-19 PEMBROLIZUMAB MERCK SHARP DOHME Approval
07/27/2017 KEYTRUDA
BLA #125514
SUPPL-23 PEMBROLIZUMAB MERCK SHARP DOHME Approval
07/27/2017 PRALUENT
BLA #125559
SUPPL-2 ALIROCUMAB SANOFI AVENTIS Approval
07/27/2017 ABILIFY MAINTENA KIT
NDA #202971
SUPPL-10 ARIPIPRAZOLE OTSUKA PHARM CO LTD Efficacy Approval
07/27/2017 DELZICOL
NDA #204412
SUPPL-8 MESALAMINE APIL Labeling Approval
07/27/2017 ACIPHEX SPRINKLE
NDA #204736
SUPPL-8 RABEPRAZOLE SODIUM AVADEL PHARMS Labeling Approval
07/27/2017 MINOXIDIL (FOR MEN)
ANDA #208092
ORIG-2 MINOXIDIL WATSON LABS INC Approval
07/27/2017 MINOXIDIL (FOR WOMEN)
ANDA #208092
ORIG-2 MINOXIDIL WATSON LABS INC Approval
07/27/2017 CALCIUM CHLORIDE 10%
ANDA #209088
ORIG-1 CALCIUM CHLORIDE LUITPOLD PHARMS INC Approval
07/28/2017 KAYEXALATE
NDA #011287
SUPPL-26 SODIUM POLYSTYRENE SULFONATE CONCORDIA PHARMS INC Labeling Approval
07/28/2017 CIPRO
NDA #019847
SUPPL-58 CIPROFLOXACIN BAYER HLTHCARE Labeling Approval
07/28/2017 VFEND
NDA #021266
SUPPL-43 VORICONAZOLE PF PRISM CV Labeling Approval
07/28/2017 VFEND
NDA #021267
SUPPL-54 VORICONAZOLE PF PRISM CV Labeling Approval
07/28/2017 VFEND
NDA #021630
SUPPL-32 VORICONAZOLE PF PRISM CV Labeling Approval
07/28/2017 FORTAZ
NDA #050578
SUPPL-61 CEFTAZIDIME TELIGENT Labeling Approval
07/28/2017 FORTAZ IN PLASTIC CONTAINER
NDA #050634
SUPPL-28 CEFTAZIDIME SODIUM TELIGENT Labeling Approval
07/28/2017 DOXYCYCLINE HYCLATE
ANDA #062432
SUPPL-32 DOXYCYCLINE HYCLATE MYLAN Manufacturing (CMC) Approval
07/28/2017 LIGNOSPAN FORTE
ANDA #088389
SUPPL-36 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
07/28/2017 LIGNOSPAN STANDARD
ANDA #088390
SUPPL-40 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
07/28/2017 LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200245
SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Manufacturing (CMC) Approval
07/28/2017 AZACITIDINE
ANDA #201537
SUPPL-2 AZACITIDINE DR REDDYS LABS LTD Labeling Approval
07/28/2017 AZACITIDINE
ANDA #201537
SUPPL-4 AZACITIDINE DR REDDYS LABS LTD Labeling Approval
07/28/2017 AZACITIDINE
ANDA #201537
SUPPL-6 AZACITIDINE DR REDDYS LABS LTD Labeling Approval
07/28/2017 MYRBETRIQ
NDA #202611
SUPPL-12 MIRABEGRON APGDI Labeling Approval
07/28/2017 DEXTROMETHORPHAN POLISTIREX
ANDA #203133
ORIG-1 DEXTROMETHORPHAN POLISTIREX AMNEAL PHARMS LLC Approval
07/28/2017 EPANED KIT
NDA #204308
SUPPL-7 ENALAPRIL MALEATE SILVERGATE PHARMS Labeling Approval
07/28/2017 PROBUPHINE
NDA #204442
SUPPL-2 BUPRENORPHINE HYDROCHLORIDE BRAEBURN PHARMS INC Labeling Approval
07/28/2017 PROBUPHINE
NDA #204442
SUPPL-4 BUPRENORPHINE HYDROCHLORIDE BRAEBURN PHARMS INC Manufacturing (CMC) Approval
07/28/2017 CEFADROXIL
ANDA #205072
ORIG-1 CEFADROXIL/CEFADROXIL HEMIHYDRATE CSPC OUYI PHARM CO Approval
07/28/2017 METHYLPHENIDATE HYDROCHLORIDE
ANDA #205327
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE OSMOTICA Approval
07/28/2017 TRIFLURIDINE
ANDA #205438
ORIG-1 TRIFLURIDINE HI-TECH PHARMACAL Approval
07/28/2017 FEBUXOSTAT
ANDA #207293
ORIG-1 FEBUXOSTAT MACLEODS PHARMS LTD Tentative Approval
07/28/2017 DARIFENACIN
ANDA #207302
ORIG-1 DARIFENACIN HYDROBROMIDE MACLEODS PHARMS LTD Approval
07/28/2017 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #207388
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ALVOGEN MALTA Approval
07/28/2017 NADOLOL
ANDA #207761
ORIG-1 NADOLOL ZYDUS PHARMS USA INC Approval
07/28/2017 QBRELIS
NDA #208401
SUPPL-2 LISINOPRIL SILVERGATE PHARMS Labeling Approval
07/28/2017 EPANED
NDA #208686
SUPPL-2 ENALAPRIL MALEATE SILVERGATE PHARMS Labeling Approval
07/28/2017 DOXYCYCLINE
ANDA #209165
ORIG-1 DOXYCYCLINE ALEMBIC PHARMS LTD Approval
07/29/2017 LUMIGAN
NDA #021275
SUPPL-27 BIMATOPROST ALLERGAN Labeling Approval
07/29/2017 LUMIGAN
NDA #022184
SUPPL-6 BIMATOPROST ALLERGAN Labeling Approval
07/29/2017 LATISSE
NDA #022369
SUPPL-11 BIMATOPROST ALLERGAN Labeling Approval
07/31/2017 H.P. ACTHAR GEL
NDA #008372
SUPPL-55 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
07/31/2017 REVATIO
NDA #021845
SUPPL-20 SILDENAFIL CITRATE PFIZER Labeling Approval
07/31/2017 VYVANSE
NDA #021977
SUPPL-34 LISDEXAMFETAMINE DIMESYLATE SHIRE DEVELOPMENT Labeling Approval
07/31/2017 REVATIO
NDA #022473
SUPPL-11 SILDENAFIL CITRATE PFIZER Labeling Approval
07/31/2017 IBUPROFEN
ANDA #070985
SUPPL-25 IBUPROFEN MERRO PHARM Labeling Approval
07/31/2017 CLONAZEPAM
ANDA #074979
SUPPL-23 CLONAZEPAM SANDOZ Labeling Approval
07/31/2017 OPDIVO
BLA #125554
SUPPL-34 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
07/31/2017 DAPTOMYCIN
ANDA #202857
SUPPL-11 DAPTOMYCIN HOSPIRA INC Labeling Approval
07/31/2017 REVATIO
NDA #203109
SUPPL-11 SILDENAFIL CITRATE PFIZER Labeling Approval
07/31/2017 KALYDECO
NDA #203188
SUPPL-26 IVACAFTOR VERTEX PHARMS Efficacy Approval
07/31/2017 ONDANSETRON HYDROCHLORIDE
ANDA #204906
ORIG-1 ONDANSETRON HYDROCHLORIDE MYLAN LABS LTD Approval
07/31/2017 ACYCLOVIR
ANDA #205510
ORIG-1 ACYCLOVIR GLENMARK PHARMS LTD Approval
07/31/2017 ROSUVASTATIN CALCIUM
ANDA #205587
ORIG-1 ROSUVASTATIN CALCIUM LUPIN LTD Approval
07/31/2017 BUDESONIDE
ANDA #206200
ORIG-1 BUDESONIDE AMNEAL PHARMS Approval
07/31/2017 ACYCLOVIR
ANDA #206437
ORIG-1 ACYCLOVIR TOLMAR Approval
07/31/2017 MAFENIDE ACETATE
ANDA #206716
ORIG-1 MAFENIDE ACETATE NOVAST LABS LTD Approval
07/31/2017 TEMOZOLOMIDE
ANDA #206750
ORIG-1 TEMOZOLOMIDE ZYDUS PHARMS USA INC Approval
07/31/2017 CLOBETASOL PROPIONATE
ANDA #206805
ORIG-1 CLOBETASOL PROPIONATE INGENUS PHARMS LLC Approval
07/31/2017 LENVIMA
NDA #206947
SUPPL-5 LENVATINIB MESYLATE EISAI INC Labeling Approval
07/31/2017 OXACILLIN SODIUM
ANDA #207147
ORIG-1 OXACILLIN SODIUM WOCKHARDT BIO AG Approval
07/31/2017 NEVIRAPINE
ANDA #207467
ORIG-1 NEVIRAPINE TECH ORGANIZED Approval
07/31/2017 METHOCARBAMOL
ANDA #207522
ORIG-1 METHOCARBAMOL SOMERSET THERAPS LLC Approval
07/31/2017 FLUOCINONIDE
ANDA #207538
ORIG-1 FLUOCINONIDE NOVEL LABS INC Approval
07/31/2017 KALYDECO
NDA #207925
SUPPL-5 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
07/31/2017 VYVANSE
NDA #208510
SUPPL-2 LISDEXAMFETAMINE DIMESYLATE SHIRE DEV LLC Labeling Approval
07/31/2017 BRIMONIDINE
ANDA #209158
ORIG-1 BRIMONIDINE PERRIGO UK FINCO Tentative 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English