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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 2017

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 April 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/03/2017 CYTOVENE
NDA #019661		 SUPPL-36 GANCICLOVIR SODIUM CHEPLAPHARM Labeling Approval
07/03/2017 MUCINEX
NDA #021282		 SUPPL-48 GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
07/03/2017 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-5 QUETIAPINE FUMARATE UNICHEM Manufacturing (CMC) Approval
07/03/2017 OMEPRAZOLE
ANDA #203481		 ORIG-1 OMEPRAZOLE BRECKENRIDGE 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 RENEW PHARMS Manufacturing (CMC) Approval
07/05/2017 PROSTIN E2
NDA #017810		 SUPPL-19 DINOPROSTONE PFIZER Labeling Approval
07/05/2017 PREPIDIL
NDA #019617		 SUPPL-17 DINOPROSTONE PFIZER Labeling Approval
07/05/2017 PROMACTA
NDA #022291		 SUPPL-18 ELTROMBOPAG OLAMINE NOVARTIS 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 KIT
NDA #207027		 SUPPL-3 ELTROMBOPAG OLAMINE NOVARTIS 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 Type 8 - Partial Rx to OTC Switch Approval
07/06/2017 INFANT'S ADVIL
NDA #020812		 SUPPL-24 IBUPROFEN HALEON US HOLDINGS Labeling Approval
07/06/2017 PEDIATRIC ADVIL
NDA #020812		 SUPPL-24 IBUPROFEN HALEON US HOLDINGS Labeling Approval
07/06/2017 PROTONIX
NDA #020987		 SUPPL-53 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/06/2017 PROTONIX IV
NDA #020988		 SUPPL-59 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/06/2017 PROTONIX
NDA #022020		 SUPPL-15 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
07/06/2017 VIMOVO
NDA #022511		 SUPPL-19 ESOMEPRAZOLE MAGNESIUM; NAPROXEN HORIZON 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 Approval
07/06/2017 MORPHINE SULFATE
ANDA #208809		 ORIG-1 MORPHINE SULFATE HIKMA Approval
07/07/2017 RECLAST
NDA #021817		 SUPPL-27 ZOLEDRONIC ACID SANDOZ Labeling Approval
07/07/2017 PRAVASTATIN SODIUM
ANDA #076341		 SUPPL-19 PRAVASTATIN SODIUM APOTEX 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 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 ENTERO VU 24%
NDA #208143		 SUPPL-4 BARIUM SULFATE BRACCO Efficacy 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 SMOOTHIE
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 HONEY
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 VARIBAR THIN HONEY
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 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 CHATTEM SANOFI Labeling Approval
07/10/2017 XYZAL
NDA #022157		 SUPPL-16 LEVOCETIRIZINE DIHYDROCHLORIDE CHATTEM SANOFI 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 INC Labeling Approval
07/10/2017 MEMANTINE HYDROCHLORIDE
ANDA #090961		 ORIG-1 MEMANTINE HYDROCHLORIDE ZYDUS LIFESCIENCES Approval
07/10/2017 OCTREOTIDE ACETATE
ANDA #091041		 SUPPL-3 OCTREOTIDE ACETATE SAGENT PHARMS INC Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-2 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-5 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-6 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-9 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
07/10/2017 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-10 DULOXETINE HYDROCHLORIDE APOTEX Labeling 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 CHARTWELL RX 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
07/12/2017 PERTZYE
BLA #022175		 SUPPL-4 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) DIGESTIVE CARE INC 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 STERISCIENCE Labeling Approval
07/12/2017 VANCOCIN HYDROCHLORIDE
ANDA #062812		 SUPPL-31 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
07/12/2017 VANCOCIN HYDROCHLORIDE
ANDA #062812		 SUPPL-32 VANCOMYCIN HYDROCHLORIDE STERISCIENCE Labeling Approval
07/12/2017 FLUOXETINE HYDROCHLORIDE
ANDA #075658		 SUPPL-29 FLUOXETINE HYDROCHLORIDE SPECGX LLC 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 PADAGIS ISRAEL Approval
07/12/2017 PRASUGREL
ANDA #205927		 ORIG-1 PRASUGREL HYDROCHLORIDE MYLAN 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 PFIZER Labeling Approval
07/13/2017 ZYVOX
NDA #021131		 SUPPL-28 LINEZOLID PFIZER Labeling Approval
07/13/2017 ZYVOX
NDA #021132		 SUPPL-33 LINEZOLID PFIZER Labeling Approval
07/13/2017 MUCINEX D
NDA #021585		 SUPPL-33 GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE RB HLTH Manufacturing (CMC) Approval
07/13/2017 MUCINEX DM
NDA #021620		 SUPPL-38 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN RB HLTH Manufacturing (CMC) 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 CHARTWELL MOLECULAR 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 HIKMA 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 MEDICURE 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 ANI PHARMS Approval
07/17/2017 TRANSDERM SCOP
NDA #017874		 SUPPL-42 SCOPOLAMINE BAXTER HLTHCARE CORP Approval
07/17/2017 MIDOZALAM HYDROCHLORIDE
ANDA #090316		 SUPPL-9 MIDAZOLAM HYDROCHLORIDE STERISCIENCE 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 PADAGIS ISRAEL Approval
07/17/2017 AMIFOSTINE
ANDA #204363		 ORIG-1 AMIFOSTINE EUGIA PHARMA SPECLTS Approval
07/17/2017 TRANEXAMIC ACID
ANDA #205228		 ORIG-1 TRANEXAMIC ACID ZYDUS PHARMS Approval
07/17/2017 LIDOCAINE
ANDA #205318		 SUPPL-1 LIDOCAINE ENCUBE 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 Approval
07/17/2017 SEVELAMER CARBONATE
ANDA #207179		 ORIG-1 SEVELAMER CARBONATE AUROBINDO PHARMA 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 ABBVIE Labeling Approval
07/18/2017 RESTASIS MULTIDOSE
NDA #050790		 SUPPL-27 CYCLOSPORINE ABBVIE Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065126		 SUPPL-2 CEFUROXIME AXETIL FOSUN PHARMA 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 CHARTWELL RX Labeling Approval
07/18/2017 CEFUROXIME AXETIL
ANDA #065308		 SUPPL-11 CEFUROXIME AXETIL AUROBINDO PHARMA Labeling Approval
07/18/2017 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #203291		 ORIG-1 DROSPIRENONE; ETHINYL ESTRADIOL HLTHCARE Approval
07/18/2017 METHOCARBAMOL
ANDA #205404		 ORIG-1 METHOCARBAMOL SAGENT PHARMS INC 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 RISING Labeling Approval
07/19/2017 AKPENTOLATE
ANDA #040165		 SUPPL-5 CYCLOPENTOLATE HYDROCHLORIDE RISING Labeling Approval
07/19/2017 MINOCIN
NDA #050649		 SUPPL-27 MINOCYCLINE HYDROCHLORIDE BAUSCH Labeling Approval
07/19/2017 EPIRUBICIN HYDROCHLORIDE
ANDA #065289		 SUPPL-5 EPIRUBICIN HYDROCHLORIDE HIKMA 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 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 ENCUBE Approval
07/20/2017 CETYLEV
NDA #207916		 SUPPL-2 ACETYLCYSTEINE ARBOR PHARMS LLC Labeling Approval
07/20/2017 BENLYSTA
BLA #761043		 ORIG-1 BELIMUMAB GLAXOSMITHKLINE LLC Approval
07/21/2017 VASOTEC
NDA #018998		 SUPPL-82 ENALAPRIL MALEATE BAUSCH Labeling Approval
07/21/2017 VASERETIC
NDA #019221		 SUPPL-47 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE BAUSCH 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 TWI PHARMS Labeling Approval
07/21/2017 ZESTORETIC
NDA #019888		 SUPPL-67 HYDROCHLOROTHIAZIDE; LISINOPRIL ALMATICA Labeling Approval
07/21/2017 LOTREL
NDA #020364		 SUPPL-65 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE SANDOZ 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 HALEON US HOLDINGS 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 Approval
07/21/2017 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #204832		 ORIG-1 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM UNICHEM 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 PHARM Approval
07/21/2017 NALTREXONE HYDROCHLORIDE
ANDA #207905		 ORIG-1 NALTREXONE HYDROCHLORIDE CHARTWELL Approval
07/21/2017 UPTRAVI
NDA #207947		 SUPPL-1 SELEXIPAG ACTELION Labeling 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 CHARTWELL MOLECULAR Labeling Approval
07/24/2017 LEVORA 0.15/30-28
ANDA #073594		 SUPPL-25 ETHINYL ESTRADIOL; LEVONORGESTREL DR REDDYS LABS SA Labeling Approval
07/24/2017 LOVASTATIN
ANDA #075935		 SUPPL-6 LOVASTATIN AUROBINDO PHARMA USA 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 ELIFEMME
ANDA #202507		 SUPPL-1 ETHINYL ESTRADIOL; LEVONORGESTREL XIROMED 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 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 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 CATALYST PHARMS Efficacy Approval
07/26/2017 OLOPATADINE HYDROCHLORIDE
ANDA #206046		 ORIG-1 OLOPATADINE HYDROCHLORIDE BAUSCH AND LOMB INC 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 CATALYST PHARMS 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 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 TAKEDA PHARMS USA 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 ABBVIE Labeling Approval
07/27/2017 ASACOL HD
NDA #021830		 SUPPL-11 MESALAMINE ABBVIE Labeling Approval
07/27/2017 LIALDA
NDA #022000		 SUPPL-16 MESALAMINE TAKEDA PHARMS USA Labeling Approval
07/27/2017 APRISO
NDA #022301		 SUPPL-9 MESALAMINE SALIX 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 REGENERON PHARMACEUTICALS 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 ABBVIE Labeling Approval
07/27/2017 ACIPHEX SPRINKLE
NDA #204736		 SUPPL-8 RABEPRAZOLE SODIUM AYTU Labeling Approval
07/27/2017 MINOXIDIL (FOR MEN)
ANDA #208092		 ORIG-2 MINOXIDIL P AND L Approval
07/27/2017 MINOXIDIL (FOR WOMEN)
ANDA #208092		 ORIG-2 MINOXIDIL P AND L Approval
07/27/2017 CALCIUM CHLORIDE 10%
ANDA #209088		 ORIG-1 CALCIUM CHLORIDE AM REGENT Approval
07/28/2017 KAYEXALATE
NDA #011287		 SUPPL-26 SODIUM POLYSTYRENE SULFONATE CONCORDIA 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 PAI HOLDINGS PHARM Labeling Approval
07/28/2017 FORTAZ IN PLASTIC CONTAINER
NDA #050634		 SUPPL-28 CEFTAZIDIME SODIUM PAI HOLDINGS PHARM 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 Labeling Approval
07/28/2017 AZACITIDINE
ANDA #201537		 SUPPL-4 AZACITIDINE DR REDDYS Labeling Approval
07/28/2017 AZACITIDINE
ANDA #201537		 SUPPL-6 AZACITIDINE DR REDDYS 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 Approval
07/28/2017 EPANED KIT
NDA #204308		 SUPPL-7 ENALAPRIL MALEATE AZURITY Labeling Approval
07/28/2017 PROBUPHINE
NDA #204442		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE TITAN PHARMS Labeling Approval
07/28/2017 PROBUPHINE
NDA #204442		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE TITAN PHARMS Manufacturing (CMC) Approval
07/28/2017 CEFADROXIL
ANDA #205072		 ORIG-1 CEFADROXIL/CEFADROXIL HEMIHYDRATE CSPC OUYI Approval
07/28/2017 METHYLPHENIDATE HYDROCHLORIDE
ANDA #205327		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE OSMOTICA PHARM US Approval
07/28/2017 TRIFLURIDINE
ANDA #205438		 ORIG-1 TRIFLURIDINE HIKMA Approval
07/28/2017 XIGDUO XR
NDA #205649		 SUPPL-8 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) 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 Approval
07/28/2017 NADOLOL
ANDA #207761		 ORIG-1 NADOLOL ZYDUS PHARMS Approval
07/28/2017 QBRELIS
NDA #208401		 SUPPL-2 LISINOPRIL AZURITY Labeling Approval
07/28/2017 EPANED
NDA #208686		 SUPPL-2 ENALAPRIL MALEATE AZURITY Labeling Approval
07/28/2017 DOXYCYCLINE
ANDA #209165		 ORIG-1 DOXYCYCLINE ALEMBIC Approval
07/29/2017 LUMIGAN
NDA #021275		 SUPPL-27 BIMATOPROST ABBVIE Labeling Approval
07/29/2017 LUMIGAN
NDA #022184		 SUPPL-6 BIMATOPROST ABBVIE Labeling Approval
07/29/2017 LATISSE
NDA #022369		 SUPPL-11 BIMATOPROST ABBVIE Labeling Approval
07/31/2017 ACTHAR GEL
NDA #008372		 SUPPL-55 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
07/31/2017 ACTHAR GEL (AUTOINJECTOR)
NDA #008372		 SUPPL-55 CORTICOTROPIN MALLINCKRODT ARD Labeling Approval
07/31/2017 REVATIO
NDA #021845		 SUPPL-20 SILDENAFIL CITRATE VIATRIS Labeling Approval
07/31/2017 VYVANSE
NDA #021977		 SUPPL-34 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
07/31/2017 REVATIO
NDA #022473		 SUPPL-11 SILDENAFIL CITRATE VIATRIS 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 Labeling Approval
07/31/2017 REVATIO
NDA #203109		 SUPPL-11 SILDENAFIL CITRATE VIATRIS 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 RISING Approval
07/31/2017 ACYCLOVIR
ANDA #205510		 ORIG-1 ACYCLOVIR GLENMARK PHARMS SA Approval
07/31/2017 ROSUVASTATIN CALCIUM
ANDA #205587		 ORIG-1 ROSUVASTATIN CALCIUM LUPIN Approval
07/31/2017 BUDESONIDE
ANDA #206200		 ORIG-1 BUDESONIDE AMNEAL PHARMS Approval
07/31/2017 ACYCLOVIR
ANDA #206437		 ORIG-1 ACYCLOVIR ANDA REPOSITORY Approval
07/31/2017 MAFENIDE ACETATE
ANDA #206716		 ORIG-1 MAFENIDE ACETATE NOVAST LABS Approval
07/31/2017 TEMOZOLOMIDE
ANDA #206750		 ORIG-1 TEMOZOLOMIDE ZYDUS PHARMS Approval
07/31/2017 CLOBETASOL PROPIONATE
ANDA #206805		 ORIG-1 CLOBETASOL PROPIONATE NOVAST LABS 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 CHARTWELL RX 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 TAKEDA PHARMS USA Labeling Approval
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