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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
June 2020

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 September 20, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2020 KETOTIFEN FUMARATE
ANDA #204059		 ORIG-1 KETOTIFEN FUMARATE BAYSHORE PHARMS LLC Approval
06/01/2020 OMEPRAZOLE MAGNESIUM
ANDA #206582		 ORIG-1 OMEPRAZOLE MAGNESIUM P AND L Approval
06/01/2020 ROCKLATAN
NDA #208259		 SUPPL-1 LATANOPROST; NETARSUDIL DIMESYLATE ALCON LABS INC Labeling Approval
06/01/2020 ROCKLATAN
NDA #208259		 SUPPL-6 LATANOPROST; NETARSUDIL DIMESYLATE ALCON LABS INC Labeling Approval
06/01/2020 MELOXICAM
ANDA #209487		 ORIG-1 MELOXICAM LUPIN LTD Approval
06/01/2020 SEYSARA
NDA #209521		 SUPPL-7 SARECYCLINE HYDROCHLORIDE ALMIRALL Labeling Approval
06/01/2020 ATAZANAVIR SULFATE
ANDA #209717		 ORIG-1 ATAZANAVIR SULFATE AMNEAL Approval
06/01/2020 LEVOMILNACIPRAN
ANDA #210805		 ORIG-1 LEVOMILNACIPRAN MSN LABORATORIES PRIVATE LTD Tentative Approval
06/01/2020 DOXYCYCLINE HYCLATE
ANDA #211584		 ORIG-1 DOXYCYCLINE HYCLATE AJANTA PHARMA LTD Approval
06/01/2020 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #211966		 ORIG-1 MAGNESIUM SULFATE BAXTER HLTHCARE CORP Approval
06/01/2020 TRIAMCINOLONE ACETONIDE
ANDA #212356		 ORIG-1 TRIAMCINOLONE ACETONIDE STRIDES PHARMA Approval
06/01/2020 TREMFYA
BLA #761061		 SUPPL-9 GUSELKUMAB JANSSEN BIOTECH Approval
06/02/2020 VIGAMOX
NDA #021598		 SUPPL-24 MOXIFLOXACIN HYDROCHLORIDE HARROW EYE Labeling Approval
06/02/2020 VOTRIENT
NDA #022465		 SUPPL-28 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
06/02/2020 CYTARABINE
ANDA #071868		 SUPPL-32 CYTARABINE HOSPIRA Labeling Approval
06/02/2020 CYTARABINE
ANDA #072168		 SUPPL-30 CYTARABINE HOSPIRA Labeling Approval
06/02/2020 CYTARABINE
ANDA #072945		 SUPPL-25 CYTARABINE HOSPIRA Labeling Approval
06/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074364		 SUPPL-21 CLOMIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074364		 SUPPL-24 CLOMIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074364		 SUPPL-27 CLOMIPRAMINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
06/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074953		 SUPPL-3 CLOMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
06/02/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #074953		 SUPPL-6 CLOMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
06/02/2020 CYTARABINE
ANDA #075383		 SUPPL-18 CYTARABINE HOSPIRA Labeling Approval
06/02/2020 LEVOFLOXACIN
ANDA #090787		 SUPPL-11 LEVOFLOXACIN APOTEX INC Labeling Approval
06/02/2020 LEVOFLOXACIN
ANDA #090787		 SUPPL-12 LEVOFLOXACIN APOTEX INC Labeling Approval
06/02/2020 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203072		 SUPPL-5 HYDROCHLOROTHIAZIDE; IRBESARTAN PRINSTON INC Labeling Approval
06/02/2020 MEMANTINE HYDROCHLORIDE
ANDA #206028		 SUPPL-3 MEMANTINE HYDROCHLORIDE LUPIN LTD Labeling Approval
06/02/2020 MEMANTINE HYDROCHLORIDE
ANDA #206028		 SUPPL-8 MEMANTINE HYDROCHLORIDE LUPIN LTD Labeling Approval
06/02/2020 NAFCILLIN SODIUM
ANDA #206761		 ORIG-1 NAFCILLIN SODIUM FRESENIUS Approval
06/02/2020 DOXYCYCLINE HYCLATE
ANDA #207558		 SUPPL-3 DOXYCYCLINE HYCLATE NOVEL LABS INC Labeling Approval
06/02/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #211977		 ORIG-1 ESOMEPRAZOLE MAGNESIUM HETERO LABS LTD III Approval
06/02/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #212507		 ORIG-1 ESOMEPRAZOLE MAGNESIUM HETERO LABS LTD III Approval
06/02/2020 FEBUXOSTAT
ANDA #213069		 ORIG-1 FEBUXOSTAT SUNSHINE Approval
06/02/2020 OXYGEN, USP
NDA #214857		 ORIG-1 OXYGEN AIR LIQUIDE CANADA INC Approval
06/03/2020 AMOXICILLIN
ANDA #064076		 SUPPL-30 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #064076		 SUPPL-31 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065228		 SUPPL-11 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065228		 SUPPL-12 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065378		 SUPPL-11 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065378		 SUPPL-12 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065387		 SUPPL-12 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 AMOXICILLIN
ANDA #065387		 SUPPL-13 AMOXICILLIN SANDOZ Labeling Approval
06/03/2020 KETAMINE HYDROCHLORIDE
ANDA #074524		 SUPPL-14 KETAMINE HYDROCHLORIDE HIKMA Labeling Approval
06/03/2020 KETAMINE HYDROCHLORIDE
ANDA #074524		 SUPPL-15 KETAMINE HYDROCHLORIDE HIKMA Labeling Approval
06/03/2020 LEFLUNOMIDE
ANDA #077087		 SUPPL-14 LEFLUNOMIDE WANBANG BIOPHARMS Manufacturing (CMC) Approval
06/03/2020 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-10 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
06/03/2020 IRINOTECAN HYDROCHLORIDE
ANDA #078589		 SUPPL-12 IRINOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
06/03/2020 IRINOTECAN HYDROCHLORIDE
ANDA #203380		 SUPPL-3 IRINOTECAN HYDROCHLORIDE QILU PHARM HAINAN Labeling Approval
06/03/2020 IRINOTECAN HYDROCHLORIDE
ANDA #203380		 SUPPL-4 IRINOTECAN HYDROCHLORIDE QILU PHARM HAINAN Labeling Approval
06/03/2020 YONDELIS
NDA #207953		 SUPPL-6 TRABECTEDIN JANSSEN PRODS Labeling Approval
06/03/2020 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208682		 SUPPL-2 MOXIFLOXACIN HYDROCHLORIDE MSN Labeling Approval
06/03/2020 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208682		 SUPPL-3 MOXIFLOXACIN HYDROCHLORIDE MSN Labeling Approval
06/03/2020 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208682		 SUPPL-5 MOXIFLOXACIN HYDROCHLORIDE MSN Labeling Approval
06/03/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #209307		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE GLAND PHARMA LTD Approval
06/03/2020 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #210789		 ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE DR REDDYS LABS SA Approval
06/03/2020 XERAVA
NDA #211109		 SUPPL-4 ERAVACYCLINE DIHYDROCHLORIDE TETRAPHASE PHARMS Manufacturing (CMC) Approval
06/03/2020 HALOBETASOL PROPIONATE
ANDA #211464		 ORIG-1 HALOBETASOL PROPIONATE PADAGIS ISRAEL Approval
06/04/2020 GLEOSTINE
NDA #017588		 SUPPL-46 LOMUSTINE LATINA PHARMA Manufacturing (CMC) Approval
06/04/2020 CEFOTAXIME
ANDA #065072		 SUPPL-12 CEFOTAXIME SODIUM HIKMA Labeling Approval
06/04/2020 CEFOTAXIME
ANDA #065072		 SUPPL-14 CEFOTAXIME SODIUM HIKMA Labeling Approval
06/04/2020 PRAVASTATIN SODIUM
ANDA #076939		 SUPPL-18 PRAVASTATIN SODIUM WATSON LABS Labeling Approval
06/04/2020 PRAVASTATIN SODIUM
ANDA #077013		 SUPPL-3 PRAVASTATIN SODIUM NORVIUM BIOSCIENCE Labeling Approval
06/04/2020 PRAVASTATIN SODIUM
ANDA #079187		 SUPPL-4 PRAVASTATIN SODIUM NORVIUM BIOSCIENCE Labeling Approval
06/04/2020 INLYTA
NDA #202324		 SUPPL-11 AXITINIB PF PRISM CV Efficacy Approval
06/04/2020 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #202594		 SUPPL-2 DROSPIRENONE; ETHINYL ESTRADIOL XIROMED Labeling Approval
06/04/2020 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #203291		 SUPPL-1 DROSPIRENONE; ETHINYL ESTRADIOL HLTHCARE Labeling Approval
06/04/2020 XIIDRA
NDA #208073		 SUPPL-5 LIFITEGRAST BAUSCH AND LOMB INC Labeling Approval
06/04/2020 MYXREDLIN
BLA #208157		 SUPPL-2 INSULIN HUMAN BAXTER HLTHCARE CORP Approval
06/04/2020 DEXYCU KIT
NDA #208912		 SUPPL-2 DEXAMETHASONE EYEPOINT PHARMS Labeling Approval
06/04/2020 ATAZANAVIR SULFATE
ANDA #210575		 ORIG-1 ATAZANAVIR SULFATE ZYDUS PHARMS Approval
06/04/2020 PROGESTERONE
ANDA #210965		 SUPPL-1 PROGESTERONE EUGIA PHARMA Labeling Approval
06/04/2020 AZITHROMYCIN
ANDA #211791		 SUPPL-1 AZITHROMYCIN ALEMBIC Labeling Approval
06/04/2020 AZITHROMYCIN
ANDA #211792		 SUPPL-1 AZITHROMYCIN ALEMBIC Labeling Approval
06/04/2020 RECARBRIO
NDA #212819		 SUPPL-2 CILASTATIN SODIUM; IMIPENEM; RELEBACTAM MSD MERCK CO Efficacy Approval
06/04/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #213567		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE QUAGEN Approval
06/04/2020 ZOLPIDEM TARTRATE
ANDA #213592		 ORIG-1 ZOLPIDEM TARTRATE BRECKENRIDGE Approval
06/05/2020 GOLYTELY
NDA #019011		 SUPPL-31 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS BRAINTREE Labeling Approval
06/05/2020 PRIFTIN
NDA #021024		 SUPPL-17 RIFAPENTINE SANOFI AVENTIS US Labeling Approval
06/05/2020 PRIFTIN
NDA #021024		 SUPPL-18 RIFAPENTINE SANOFI AVENTIS US Labeling Approval
06/05/2020 CAPRELSA
NDA #022405		 SUPPL-16 VANDETANIB GENZYME CORP Labeling Approval
06/05/2020 LORAZEPAM
ANDA #076150		 SUPPL-3 LORAZEPAM INTL MEDICATION SYS Labeling Approval
06/05/2020 FLUVASTATIN SODIUM
ANDA #078407		 SUPPL-3 FLUVASTATIN SODIUM TEVA PHARMS Labeling Approval
06/05/2020 ZALTRAP
BLA #125418		 SUPPL-47 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
06/05/2020 NATPARA
BLA #125511		 SUPPL-21 PARATHYROID HORMONE NPS PHARMS INC Approval
06/05/2020 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #210966		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE EUGIA PHARMA Approval
06/05/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211920		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE GLAND PHARMA LTD Approval
06/05/2020 IMFINZI
BLA #761069		 SUPPL-20 DURVALUMAB ASTRAZENECA UK LTD Approval
06/07/2020 CYKLOKAPRON
NDA #019281		 SUPPL-44 TRANEXAMIC ACID PFIZER Labeling Approval
06/08/2020 TOPAMAX
NDA #020505		 SUPPL-61 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/08/2020 TOPAMAX
NDA #020844		 SUPPL-52 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/08/2020 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-52 TOPIRAMATE JANSSEN PHARMS Labeling Approval
06/08/2020 CEFOTAXIME
ANDA #065071		 SUPPL-11 CEFOTAXIME SODIUM HIKMA Labeling Approval
06/08/2020 CEFOTAXIME
ANDA #065071		 SUPPL-12 CEFOTAXIME SODIUM HIKMA Labeling Approval
06/08/2020 CEFOTAXIME
ANDA #065071		 SUPPL-14 CEFOTAXIME SODIUM HIKMA Labeling Approval
06/08/2020 LOPERAMIDE HYDROCHLORIDE
ANDA #075232		 SUPPL-44 LOPERAMIDE HYDROCHLORIDE L PERRIGO CO Labeling Approval
06/08/2020 LOPERAMIDE HYDROCHLORIDE
ANDA #075232		 SUPPL-46 LOPERAMIDE HYDROCHLORIDE L PERRIGO CO Labeling Approval
06/08/2020 ECONAZOLE NITRATE
ANDA #076005		 SUPPL-10 ECONAZOLE NITRATE TARO Labeling Approval
06/08/2020 GANCICLOVIR SODIUM
ANDA #090658		 SUPPL-3 GANCICLOVIR SODIUM FRESENIUS KABI USA Labeling Approval
06/08/2020 GANCICLOVIR SODIUM
ANDA #090658		 SUPPL-4 GANCICLOVIR SODIUM FRESENIUS KABI USA Labeling Approval
06/08/2020 HEPARIN SODIUM
ANDA #091682		 SUPPL-7 HEPARIN SODIUM SANDOZ Labeling Approval
06/08/2020 HEPARIN SODIUM
ANDA #201002		 SUPPL-5 HEPARIN SODIUM SANDOZ Labeling Approval
06/08/2020 BINOSTO
NDA #202344		 SUPPL-13 ALENDRONATE SODIUM RADIUS Labeling Approval
06/08/2020 MARQIBO KIT
NDA #202497		 SUPPL-11 VINCRISTINE SULFATE ACROTECH Labeling Approval
06/08/2020 GANCICLOVIR SODIUM
ANDA #202624		 SUPPL-2 GANCICLOVIR SODIUM AM REGENT Labeling Approval
06/08/2020 GANCICLOVIR SODIUM
ANDA #202624		 SUPPL-3 GANCICLOVIR SODIUM AM REGENT Labeling Approval
06/08/2020 GANCICLOVIR SODIUM
ANDA #204950		 SUPPL-2 GANCICLOVIR SODIUM ENDO OPERATIONS Labeling Approval
06/08/2020 EVEROLIMUS
ANDA #207486		 ORIG-1 EVEROLIMUS HIKMA Approval
06/08/2020 AZACITIDINE
ANDA #209337		 ORIG-1 AZACITIDINE EUROHLTH INTL SARL Approval
06/08/2020 ECONAZOLE NITRATE
ANDA #210364		 SUPPL-2 ECONAZOLE NITRATE AUROBINDO PHARMA USA Labeling Approval
06/08/2020 EVEROLIMUS
ANDA #212936		 ORIG-1 EVEROLIMUS MYLAN Approval
06/08/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #213432		 ORIG-1 SUCCINYLCHOLINE CHLORIDE AMPHASTAR PHARMS INC Approval
06/09/2020 PRIFTIN
NDA #021024		 SUPPL-20 RIFAPENTINE SANOFI AVENTIS US Labeling Approval
06/09/2020 LASTACAFT
NDA #022134		 SUPPL-7 ALCAFTADINE ABBVIE Labeling Approval
06/09/2020 BRIDION
NDA #022225		 SUPPL-6 SUGAMMADEX SODIUM MSD SUB MERCK Efficacy Approval
06/09/2020 TRAZODONE HYDROCHLORIDE
ANDA #071514		 SUPPL-22 TRAZODONE HYDROCHLORIDE ALVOGEN Labeling Approval
06/09/2020 TRAZODONE HYDROCHLORIDE
ANDA #071636		 SUPPL-30 TRAZODONE HYDROCHLORIDE ALVOGEN Labeling Approval
06/09/2020 BUPIVACAINE HYDROCHLORIDE
ANDA #071810		 SUPPL-21 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/09/2020 LORAZEPAM
ANDA #074243		 SUPPL-18 LORAZEPAM HOSPIRA Labeling Approval
06/09/2020 LORAZEPAM
ANDA #074243		 SUPPL-19 LORAZEPAM HOSPIRA Labeling Approval
06/09/2020 BETAMETHASONE DIPROPIONATE
ANDA #074304		 SUPPL-25 BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC Labeling Approval
06/09/2020 BETAMETHASONE DIPROPIONATE
ANDA #074304		 SUPPL-26 BETAMETHASONE DIPROPIONATE ACTAVIS MID ATLANTIC Labeling Approval
06/09/2020 BETAMETHASONE DIPROPIONATE
ANDA #075373		 SUPPL-11 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
06/09/2020 BETAMETHASONE DIPROPIONATE
ANDA #075373		 SUPPL-12 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
06/09/2020 PROLIA
BLA #125320		 SUPPL-203 DENOSUMAB AMGEN Approval
06/09/2020 XGEVA
BLA #125320		 SUPPL-203 DENOSUMAB AMGEN Approval
06/09/2020 CISATRACURIUM BESYLATE
ANDA #200159		 SUPPL-7 CISATRACURIUM BESYLATE SANDOZ INC Labeling Approval
06/09/2020 LAMOTRIGINE
ANDA #202383		 SUPPL-10 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
06/09/2020 LAMOTRIGINE
ANDA #202383		 SUPPL-11 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
06/09/2020 ZOLMITRIPTAN
ANDA #202890		 SUPPL-8 ZOLMITRIPTAN ZYDUS PHARMS USA INC Labeling Approval
06/09/2020 LAMOTRIGINE
ANDA #207497		 SUPPL-2 LAMOTRIGINE AMNEAL PHARMS Labeling Approval
06/09/2020 LAMOTRIGINE
ANDA #207497		 SUPPL-3 LAMOTRIGINE AMNEAL PHARMS Labeling Approval
06/09/2020 ERTAPENEM SODIUM
ANDA #207647		 SUPPL-4 ERTAPENEM SODIUM SAVIOR LIFETEC CORP Labeling Approval
06/09/2020 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #207956		 SUPPL-4 SODIUM CHLORIDE LABORATORIOS GRIFOLS Labeling Approval
06/09/2020 ETHACRYNATE SODIUM
ANDA #208663		 ORIG-1 ETHACRYNATE SODIUM STERIMAX Approval
06/09/2020 ERTAPENEM SODIUM
ANDA #209133		 SUPPL-3 ERTAPENEM SODIUM EUGIA PHARMA Labeling Approval
06/09/2020 CLOBAZAM
ANDA #209853		 ORIG-1 CLOBAZAM APOTEX Approval
06/09/2020 BEOVU
BLA #761125		 SUPPL-4 brolucizumab-dbll NOVARTIS PHARMS CORP Approval
06/10/2020 MYSOLINE
NDA #009170		 SUPPL-40 PRIMIDONE VALEANT Manufacturing (CMC) Approval
06/10/2020 LIPIODOL
NDA #009190		 SUPPL-29 ETHIODIZED OIL GUERBET Labeling Approval
06/10/2020 LIPIODOL
NDA #009190		 SUPPL-31 ETHIODIZED OIL GUERBET Labeling Approval
06/10/2020 POTASSIUM CHLORIDE
ANDA #077419		 SUPPL-18 POTASSIUM CHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/10/2020 LEVOFLOXACIN
ANDA #078424		 SUPPL-19 LEVOFLOXACIN LUPIN Labeling Approval
06/10/2020 LEVOFLOXACIN
ANDA #078424		 SUPPL-20 LEVOFLOXACIN LUPIN Labeling Approval
06/10/2020 MINOXIDIL
ANDA #091344		 SUPPL-20 MINOXIDIL PERRIGO PHARMA INTL Labeling Approval
06/10/2020 OPDIVO
BLA #125554		 SUPPL-81 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
06/10/2020 POTASSIUM CHLORIDE
ANDA #200185		 SUPPL-6 POTASSIUM CHLORIDE PADAGIS US Labeling Approval
06/10/2020 SODIUM NITROPRUSSIDE
ANDA #210882		 SUPPL-1 SODIUM NITROPRUSSIDE SOMERSET THERAPS LLC Labeling Approval
06/10/2020 ALBENDAZOLE
ANDA #211636		 ORIG-1 ALBENDAZOLE CHARTWELL RX Approval
06/10/2020 FLUOXETINE HYDROCHLORIDE
ANDA #213265		 ORIG-1 FLUOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
06/10/2020 NYVEPRIA
BLA #761111		 ORIG-1 PEGFILGRASTIM-APGF HOSPIRA INC Approval
06/11/2020 FENTANYL CITRATE PRESERVATIVE FREE
ANDA #072786		 SUPPL-14 FENTANYL CITRATE HOSPIRA Labeling Approval
06/11/2020 FENTANYL CITRATE PRESERVATIVE FREE
ANDA #072786		 SUPPL-16 FENTANYL CITRATE HOSPIRA Labeling Approval
06/11/2020 FENTANYL CITRATE PRESERVATIVE FREE
ANDA #072786		 SUPPL-26 FENTANYL CITRATE HOSPIRA Labeling Approval
06/11/2020 BETAMETHASONE DIPROPIONATE
ANDA #076753		 SUPPL-9 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
06/11/2020 ZIDOVUDINE
ANDA #077268		 SUPPL-14 ZIDOVUDINE AUROBINDO Labeling Approval
06/11/2020 ZIDOVUDINE
ANDA #077268		 SUPPL-15 ZIDOVUDINE AUROBINDO Labeling Approval
06/11/2020 ZIDOVUDINE
ANDA #077268		 SUPPL-16 ZIDOVUDINE AUROBINDO Labeling Approval
06/11/2020 ZIDOVUDINE
ANDA #077268		 SUPPL-18 ZIDOVUDINE AUROBINDO Labeling Approval
06/11/2020 MICONAZOLE NITRATE
ANDA #079114		 SUPPL-14 MICONAZOLE NITRATE PERRIGO R AND D Labeling Approval
06/11/2020 LAMIVUDINE
ANDA #090198		 SUPPL-14 LAMIVUDINE MACLEODS PHARMS LTD Labeling Approval
06/11/2020 NYLIA 7/7/7
ANDA #207054		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE AUROBINDO PHARMA Labeling Approval
06/11/2020 SEMGLEE
BLA #210605		 ORIG-1 INSULIN GLARGINE MYLAN PHARMS INC Approval
06/11/2020 SODIUM NITROPRUSSIDE
ANDA #210763		 SUPPL-2 SODIUM NITROPRUSSIDE MYLAN LABS LTD Labeling Approval
06/11/2020 LEVETIRACETAM
ANDA #212688		 ORIG-1 LEVETIRACETAM OVERSEAS Approval
06/11/2020 SILDENAFIL CITRATE
ANDA #213032		 ORIG-1 SILDENAFIL CITRATE SUNSHINE Approval
06/11/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #213318		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE CAPLIN Approval
06/11/2020 ERELZI
BLA #761042		 SUPPL-12 ETANERCEPT-SZZS SANDOZ Approval
06/11/2020 UPLIZNA
BLA #761142		 ORIG-1 INEBILIZUMAB-CDON VIELA BIO Approval
06/12/2020 STRENSIQ
BLA #125513		 SUPPL-18 ASFOTASE ALFA ALEXION PHARM Approval
06/12/2020 LATANOPROST
ANDA #200925		 SUPPL-4 LATANOPROST AMRING PHARMS Labeling Approval
06/12/2020 LATANOPROST
ANDA #200925		 SUPPL-5 LATANOPROST AMRING PHARMS Labeling Approval
06/12/2020 DICLOFENAC SODIUM
ANDA #202769		 SUPPL-3 DICLOFENAC SODIUM PAI HOLDINGS PHARM Manufacturing (CMC) Approval
06/12/2020 TIVICAY
NDA #204790		 SUPPL-25 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Efficacy Approval
06/12/2020 SILDENAFIL CITRATE
ANDA #208494		 ORIG-1 SILDENAFIL CITRATE REYOUNG Approval
06/12/2020 VENCLEXTA
NDA #208573		 SUPPL-17 VENETOCLAX ABBVIE Labeling Approval
06/12/2020 IRINOTECAN HYDROCHLORIDE
ANDA #208718		 SUPPL-5 IRINOTECAN HYDROCHLORIDE SHILPA Labeling Approval
06/12/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #213229		 ORIG-1 SUCCINYLCHOLINE CHLORIDE HIKMA Approval
06/12/2020 FENOFIBRATE
ANDA #213864		 ORIG-1 FENOFIBRATE MANKIND PHARMA Approval
06/12/2020 TIVICAY PD
NDA #213983		 ORIG-1 DOLUTEGRAVIR SODIUM VIIV HLTHCARE Type 3 - New Dosage Form Approval
06/15/2020 LEVOPHED
NDA #007513		 SUPPL-38 NOREPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
06/15/2020 CAPRELSA
NDA #022405		 SUPPL-17 VANDETANIB GENZYME CORP Labeling Approval
06/15/2020 BUPRENORPHINE HYDROCHLORIDE
ANDA #076931		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
06/15/2020 BETAMETHASONE DIPROPIONATE
ANDA #077111		 SUPPL-6 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
06/15/2020 BETAMETHASONE DIPROPIONATE
ANDA #077111		 SUPPL-7 BETAMETHASONE DIPROPIONATE FOUGERA PHARMS Labeling Approval
06/15/2020 BETAMETHASONE DIPROPIONATE
ANDA #077477		 SUPPL-9 BETAMETHASONE DIPROPIONATE TARO Labeling Approval
06/15/2020 SIMVASTATIN
ANDA #090383		 SUPPL-11 SIMVASTATIN MICRO LABS Labeling Approval
06/15/2020 SUBLOCADE
NDA #209819		 SUPPL-16 BUPRENORPHINE INDIVIOR REMS Approval
06/15/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #210093		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS PURACAP PHARM LLC Approval
06/15/2020 GEMCITABINE HYDROCHLORIDE
ANDA #210383		 SUPPL-2 GEMCITABINE HYDROCHLORIDE NOVAST LABS Labeling Approval
06/15/2020 DEFERASIROX
ANDA #210727		 ORIG-2 DEFERASIROX STEVENS J Approval
06/15/2020 DEFERASIROX
ANDA #211383		 ORIG-2 DEFERASIROX ZYDUS PHARMS Approval
06/15/2020 DEFERASIROX
ANDA #211641		 ORIG-2 DEFERASIROX SUN PHARM Approval
06/15/2020 DEFERASIROX
ANDA #211824		 ORIG-2 DEFERASIROX ALEMBIC Approval
06/15/2020 DEFERASIROX
ANDA #211852		 ORIG-2 DEFERASIROX CIPLA Approval
06/15/2020 DEFERASIROX
ANDA #212995		 ORIG-2 DEFERASIROX PIRAMAL HLTHCARE UK Approval
06/15/2020 ZEPZELCA
NDA #213702		 ORIG-1 LURBINECTEDIN JAZZ Type 1 - New Molecular Entity Approval
06/15/2020 LYUMJEV
BLA #761109		 ORIG-1 INSULIN LISPRO-AABC ELI LILLY AND CO Approval
06/16/2020 ELMIRON
NDA #020193		 SUPPL-14 PENTOSAN POLYSULFATE SODIUM JANSSEN PHARMS Labeling Approval
06/16/2020 AZILECT
NDA #021641		 SUPPL-21 RASAGILINE MESYLATE TEVA Labeling Approval
06/16/2020 MYCOPHENOLATE MOFETIL
ANDA #065410		 SUPPL-13 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
06/16/2020 MYCOPHENOLATE MOFETIL
ANDA #065413		 SUPPL-14 MYCOPHENOLATE MOFETIL HIKMA Labeling Approval
06/16/2020 ILARIS
BLA #125319		 SUPPL-97 CANAKINUMAB NOVARTIS PHARMS Approval
06/16/2020 COSENTYX
BLA #125504		 SUPPL-35 SECUKINUMAB NOVARTIS PHARMS CORP Approval
06/16/2020 KEYTRUDA
BLA #125514		 SUPPL-71 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/16/2020 KEYTRUDA
BLA #125514		 SUPPL-90 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/16/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #201072		 SUPPL-1 DEXMEDETOMIDINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/16/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #201072		 SUPPL-2 DEXMEDETOMIDINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/16/2020 ENTECAVIR
ANDA #202122		 SUPPL-8 ENTECAVIR TEVA PHARMS USA Labeling Approval
06/16/2020 BEXAROTENE
ANDA #203663		 ORIG-1 BEXAROTENE HIKMA Approval
06/16/2020 OLOPATADINE HYDROCHLORIDE
ANDA #204620		 ORIG-1 OLOPATADINE HYDROCHLORIDE RISING PHARMA Approval
06/16/2020 ENTECAVIR
ANDA #206652		 SUPPL-6 ENTECAVIR AMNEAL PHARMS Labeling Approval
06/16/2020 SPINRAZA
NDA #209531		 SUPPL-10 NUSINERSEN SODIUM BIOGEN IDEC Efficacy Approval
06/16/2020 DEFERASIROX
ANDA #210945		 ORIG-2 DEFERASIROX MSN Approval
06/16/2020 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #211170		 ORIG-1 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE WES PHARMA INC Approval
06/16/2020 PREDNISONE
ANDA #213385		 ORIG-1 PREDNISONE AMNEAL Approval
06/16/2020 FENOFIBRIC ACID
ANDA #213450		 ORIG-1 CHOLINE FENOFIBRATE MICRO LABS Approval
06/16/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #214246		 ORIG-1 SUCCINYLCHOLINE CHLORIDE GLAND PHARMA LTD Approval
06/16/2020 MYLOTARG
BLA #761060		 SUPPL-4 GEMTUZUMAB OZOGAMICIN WYETH PHARMS INC Approval
06/17/2020 EPI E Z PEN JR
NDA #019430		 SUPPL-89 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
06/17/2020 EPIPEN
NDA #019430		 SUPPL-89 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
06/17/2020 EPIPEN E Z PEN
NDA #019430		 SUPPL-89 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
06/17/2020 EPIPEN JR.
NDA #019430		 SUPPL-89 EPINEPHRINE MYLAN SPECIALITY LP Labeling Approval
06/17/2020 TEKTURNA
NDA #021985		 SUPPL-39 ALISKIREN HEMIFUMARATE NODEN PHARMA Labeling Approval
06/17/2020 AMOXICILLIN
ANDA #065119		 SUPPL-26 AMOXICILLIN TEVA Labeling Approval
06/17/2020 ONCASPAR
BLA #103411		 SUPPL-5198 PEGASPARGASE SIGMA TAU Approval
06/17/2020 TYSABRI
BLA #125104		 SUPPL-968 NATALIZUMAB BIOGEN IDEC Approval
06/17/2020 TYSABRI
BLA #125104		 SUPPL-969 NATALIZUMAB BIOGEN IDEC Approval
06/17/2020 ORENCIA
BLA #125118		 SUPPL-194 ABATACEPT BRISTOL MYERS SQUIBB Approval
06/17/2020 ORENCIA
BLA #125118		 SUPPL-199 ABATACEPT BRISTOL MYERS SQUIBB Approval
06/17/2020 ORENCIA
BLA #125118		 SUPPL-225 ABATACEPT BRISTOL MYERS SQUIBB Approval
06/17/2020 BOSULIF
NDA #203341		 SUPPL-18 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
06/17/2020 ICLUSIG
NDA #203469		 SUPPL-32 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
06/17/2020 REXULTI
NDA #205422		 SUPPL-5 BREXPIPRAZOLE OTSUKA Labeling Approval
06/17/2020 VIBERZI
NDA #206940		 SUPPL-7 ELUXADOLINE ABBVIE Labeling Approval
06/17/2020 ACYCLOVIR SODIUM
ANDA #207919		 ORIG-1 ACYCLOVIR SODIUM DR REDDYS Approval
06/17/2020 PEMFEXY
NDA #209472		 SUPPL-1 PEMETREXED EAGLE PHARMS Manufacturing (CMC) Approval
06/17/2020 TERIFLUNOMIDE
ANDA #209677		 ORIG-1 TERIFLUNOMIDE SOLA PHARMS Approval
06/17/2020 BETAMETHASONE DIPROPIONATE
ANDA #211722		 ORIG-1 BETAMETHASONE DIPROPIONATE TARO Approval
06/17/2020 CHLORZOXAZONE
ANDA #212898		 ORIG-1 CHLORZOXAZONE TEVA PHARMS USA INC Approval
06/18/2020 SODIUM CHLORIDE 14.6%
NDA #018897		 SUPPL-24 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/18/2020 SODIUM CHLORIDE 23.4%
NDA #018897		 SUPPL-24 SODIUM CHLORIDE HOSPIRA Manufacturing (CMC) Approval
06/18/2020 RETROVIR
NDA #019655		 SUPPL-59 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
06/18/2020 RETROVIR
NDA #019910		 SUPPL-46 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
06/18/2020 RETROVIR
NDA #019951		 SUPPL-37 ZIDOVUDINE VIIV HLTHCARE Labeling Approval
06/18/2020 APTIVUS
NDA #021814		 SUPPL-21 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
06/18/2020 APTIVUS
NDA #022292		 SUPPL-14 TIPRANAVIR BOEHRINGER INGELHEIM Labeling Approval
06/18/2020 AMIODARONE HYDROCHLORIDE
ANDA #077610		 SUPPL-3 AMIODARONE HYDROCHLORIDE ACELLA Labeling Approval
06/18/2020 ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #077857		 SUPPL-35 ENOXAPARIN SODIUM SANDOZ Labeling Approval
06/18/2020 DOXYCYCLINE
ANDA #091406		 SUPPL-3 DOXYCYCLINE HYCLATE MYLAN LABS LTD Labeling Approval
06/18/2020 DOXYCYCLINE
ANDA #091406		 SUPPL-4 DOXYCYCLINE HYCLATE MYLAN LABS LTD Labeling Approval
06/18/2020 DOXYCYCLINE
ANDA #091406		 SUPPL-12 DOXYCYCLINE HYCLATE MYLAN LABS LTD Labeling Approval
06/18/2020 ENTECAVIR
ANDA #206217		 SUPPL-10 ENTECAVIR AUROBINDO PHARMA Labeling Approval
06/18/2020 ENTECAVIR
ANDA #206745		 SUPPL-5 ENTECAVIR ZYDUS PHARMS Labeling Approval
06/18/2020 ENTECAVIR
ANDA #206872		 SUPPL-4 ENTECAVIR CIPLA Labeling Approval
06/18/2020 SEVELAMER CARBONATE
ANDA #207179		 SUPPL-3 SEVELAMER CARBONATE AUROBINDO PHARMA Labeling Approval
06/18/2020 SEVELAMER CARBONATE
ANDA #207179		 SUPPL-6 SEVELAMER CARBONATE AUROBINDO PHARMA Labeling Approval
06/18/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207985		 ORIG-1 FINGOLIMOD HYDROCHLORIDE GLENMARK PHARMS LTD Approval
06/18/2020 ICATIBANT ACETATE
ANDA #208317		 ORIG-1 ICATIBANT ACETATE FRESENIUS KABI USA Approval
06/18/2020 DEFERASIROX
ANDA #211383		 SUPPL-1 DEFERASIROX ZYDUS PHARMS Labeling Approval
06/18/2020 PROPAFENONE HYDROCHLORIDE
ANDA #212928		 ORIG-1 PROPAFENONE HYDROCHLORIDE TWI PHARMS Approval
06/18/2020 TAZVERIK
NDA #213400		 ORIG-1 TAZEMETOSTAT HYDROBROMIDE EPIZYME INC Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
06/18/2020 ADAPALENE
ANDA #213508		 ORIG-1 ADAPALENE ALEMBIC Approval
06/18/2020 DUPIXENT
BLA #761055		 SUPPL-15 DUPILUMAB REGENERON PHARMACEUTICALS Approval
06/18/2020 DUPIXENT
BLA #761055		 SUPPL-17 DUPILUMAB REGENERON PHARMACEUTICALS Approval
06/18/2020 CRYSVITA
BLA #761068		 SUPPL-5 BUROSUMAB-TWZA KYOWA KIRIN Approval
06/19/2020 NEXAVAR
NDA #021923		 SUPPL-22 SORAFENIB TOSYLATE BAYER HLTHCARE Labeling Approval
06/19/2020 ALPROSTADIL
ANDA #075196		 SUPPL-20 ALPROSTADIL MEITHEAL Labeling Approval
06/19/2020 ALPROSTADIL
ANDA #075196		 SUPPL-21 ALPROSTADIL MEITHEAL Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #077219		 SUPPL-10 IRINOTECAN HYDROCHLORIDE CIPLA LTD Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #077219		 SUPPL-11 IRINOTECAN HYDROCHLORIDE CIPLA LTD Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-7 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-10 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-11 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #078796		 SUPPL-10 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
06/19/2020 IRINOTECAN HYDROCHLORIDE
ANDA #078796		 SUPPL-11 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
06/19/2020 IBANDRONATE SODIUM
ANDA #078997		 SUPPL-4 IBANDRONATE SODIUM DR REDDYS LABS LTD Labeling Approval
06/19/2020 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #201663		 SUPPL-2 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
06/19/2020 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #201663		 SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL LUPIN LTD Labeling Approval
06/19/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202585		 SUPPL-1 DEXMEDETOMIDINE HYDROCHLORIDE RISING PHARMA Labeling Approval
06/19/2020 SODIUM THIOSULFATE
NDA #203923		 SUPPL-4 SODIUM THIOSULFATE HOPE PHARMS Labeling Approval
06/19/2020 SIVEXTRO
NDA #205435		 SUPPL-12 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Efficacy Approval
06/19/2020 SIVEXTRO
NDA #205436		 SUPPL-7 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Efficacy Approval
06/19/2020 GIMOTI
NDA #209388		 ORIG-1 METOCLOPRAMIDE HYDROCHLORIDE EVOKE PHARMA INC Type 3 - New Dosage Form and Type 4 - New Combination Approval
06/19/2020 POTASSIUM CHLORIDE
ANDA #210241		 SUPPL-2 POTASSIUM CHLORIDE NOVEL LABS INC Labeling Approval
06/19/2020 POTASSIUM CHLORIDE
ANDA #210241		 SUPPL-3 POTASSIUM CHLORIDE NOVEL LABS INC Labeling Approval
06/19/2020 POTASSIUM CHLORIDE
ANDA #210902		 SUPPL-2 POTASSIUM CHLORIDE AMNEAL Labeling Approval
06/19/2020 METHYLPHENIDATE
ANDA #210924		 ORIG-1 METHYLPHENIDATE ACTAVIS ELIZABETH Approval
06/19/2020 TERBUTALINE SULFATE
ANDA #211832		 ORIG-1 TERBUTALINE SULFATE TWI PHARMS Approval
06/19/2020 DOFETILIDE
ANDA #213338		 ORIG-1 DOFETILIDE ACCORD HLTHCARE Approval
06/22/2020 LEVAQUIN
NDA #020634		 SUPPL-73 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
06/22/2020 LOPERAMIDE HYDROCHLORIDE
NDA #021855		 SUPPL-14 LOPERAMIDE HYDROCHLORIDE BIONPHARMA Labeling Approval
06/22/2020 PENICILLIN G SODIUM
ANDA #065068		 SUPPL-22 PENICILLIN G SODIUM SANDOZ Labeling Approval
06/22/2020 LORAZEPAM
ANDA #074793		 SUPPL-2 LORAZEPAM ENDO OPERATIONS Labeling Approval
06/22/2020 AMIODARONE HYDROCHLORIDE
ANDA #076163		 SUPPL-17 AMIODARONE HYDROCHLORIDE DR REDDYS Labeling Approval
06/22/2020 AMIODARONE HYDROCHLORIDE
ANDA #076232		 SUPPL-1 AMIODARONE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076665		 SUPPL-9 FLUCONAZOLE CHARTWELL Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076665		 SUPPL-10 FLUCONAZOLE CHARTWELL Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076665		 SUPPL-11 FLUCONAZOLE CHARTWELL Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076957		 SUPPL-5 FLUCONAZOLE THINQ PHARM-CRO PVT Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076957		 SUPPL-6 FLUCONAZOLE THINQ PHARM-CRO PVT Labeling Approval
06/22/2020 FLUCONAZOLE
ANDA #076957		 SUPPL-8 FLUCONAZOLE THINQ PHARM-CRO PVT Labeling Approval
06/22/2020 AMIODARONE HYDROCHLORIDE
ANDA #077834		 SUPPL-3 AMIODARONE HYDROCHLORIDE ACELLA Labeling Approval
06/22/2020 ZOLPIDEM TARTRATE
ANDA #078184		 SUPPL-5 ZOLPIDEM TARTRATE INVAGEN PHARMS Labeling Approval
06/22/2020 GEMFIBROZIL
ANDA #078599		 SUPPL-3 GEMFIBROZIL HIKMA PHARMS Labeling Approval
06/22/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #091465		 SUPPL-2 DEXMEDETOMIDINE HYDROCHLORIDE SANDOZ Labeling Approval
06/22/2020 TERIFLUNOMIDE
ANDA #209702		 SUPPL-1 TERIFLUNOMIDE NORVIUM BIOSCIENCE Labeling Approval
06/22/2020 XPOVIO
NDA #212306		 SUPPL-1 SELINEXOR KARYOPHARM THERAPS Efficacy Approval
06/22/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #213219		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE MICRO LABS Approval
06/22/2020 CLOMIPRAMINE HYDROCHLORIDE
ANDA #213221		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE RK PHARMA Approval
06/23/2020 TRUVADA
NDA #021752		 SUPPL-61 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Labeling Approval
06/23/2020 TYGACIL
NDA #021821		 SUPPL-49 TIGECYCLINE PF PRISM CV Labeling Approval
06/23/2020 AMIODARONE HYDROCHLORIDE
ANDA #075424		 SUPPL-31 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
06/23/2020 AMIODARONE HYDROCHLORIDE
ANDA #076217		 SUPPL-33 AMIODARONE HYDROCHLORIDE MYLAN INSTITUTIONAL Labeling Approval
06/23/2020 AMIODARONE HYDROCHLORIDE
ANDA #076362		 SUPPL-25 AMIODARONE HYDROCHLORIDE TARO Labeling Approval
06/23/2020 AMIODARONE HYDROCHLORIDE
ANDA #077161		 SUPPL-10 AMIODARONE HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
06/23/2020 SIMVASTATIN
ANDA #078155		 SUPPL-35 SIMVASTATIN ACCORD HLTHCARE Labeling Approval
06/23/2020 BUPRENORPHINE HYDROCHLORIDE
ANDA #078331		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE AM REGENT Labeling Approval
06/23/2020 BUPRENORPHINE HYDROCHLORIDE
ANDA #078331		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE AM REGENT Labeling Approval
06/23/2020 OPDIVO
BLA #125554		 SUPPL-83 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
06/23/2020 MEKINIST
NDA #204114		 SUPPL-16 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Labeling Approval
06/23/2020 GEMCITABINE HYDROCHLORIDE
ANDA #204549		 SUPPL-3 GEMCITABINE HYDROCHLORIDE ACTAVIS INC Labeling Approval
06/23/2020 BETAMETHASONE DIPROPIONATE
ANDA #206389		 SUPPL-1 BETAMETHASONE DIPROPIONATE ENCUBE Labeling Approval
06/23/2020 BETAMETHASONE DIPROPIONATE
ANDA #206389		 SUPPL-2 BETAMETHASONE DIPROPIONATE ENCUBE Labeling Approval
06/23/2020 BUPRENORPHINE HYDROCHLORIDE
ANDA #206586		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
06/23/2020 BUPRENORPHINE HYDROCHLORIDE
ANDA #206586		 SUPPL-5 BUPRENORPHINE HYDROCHLORIDE ENDO OPERATIONS Labeling Approval
06/23/2020 ATORVASTATIN CALCIUM
ANDA #208478		 ORIG-1 ATORVASTATIN CALCIUM PERRIGO R AND D Approval
06/23/2020 PANTOPRAZOLE SODIUM
NDA #209463		 SUPPL-6 PANTOPRAZOLE SODIUM HIKMA Labeling Approval
06/23/2020 TERIFLUNOMIDE
ANDA #209638		 SUPPL-3 TERIFLUNOMIDE AUROBINDO PHARMA Labeling Approval
06/23/2020 MECLIZINE HYDROCHLORIDE
ANDA #213957		 ORIG-1 MECLIZINE HYDROCHLORIDE ZYDUS LIFESCIENCES Approval
06/24/2020 ATACAND
NDA #020838		 SUPPL-41 CANDESARTAN CILEXETIL ANI PHARMS Labeling Approval
06/24/2020 ATROPINE SULFATE
NDA #021146		 SUPPL-22 ATROPINE SULFATE HOSPIRA Labeling Approval
06/24/2020 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-35 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
06/24/2020 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-36 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
06/24/2020 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-37 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
06/24/2020 BENAZEPRIL HYDROCHLORIDE
ANDA #076344		 SUPPL-18 BENAZEPRIL HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
06/24/2020 NEVIRAPINE
ANDA #078584		 SUPPL-18 NEVIRAPINE HETERO LABS LTD III Labeling Approval
06/24/2020 NEVIRAPINE
ANDA #078584		 SUPPL-19 NEVIRAPINE HETERO LABS LTD III Labeling Approval
06/24/2020 KEYTRUDA
BLA #125514		 SUPPL-68 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/24/2020 KEYTRUDA
BLA #125514		 SUPPL-92 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/24/2020 PROCYSBI
NDA #203389		 SUPPL-23 CYSTEAMINE BITARTRATE HORIZON Labeling Approval
06/24/2020 SODIUM FLUORIDE F-18
ANDA #203777		 SUPPL-1 SODIUM FLUORIDE F-18 3D IMAGING DRUG Manufacturing (CMC) Approval
06/24/2020 FLUDEOXYGLUCOSE F18
ANDA #203778		 SUPPL-2 FLUDEOXYGLUCOSE F-18 3D IMAGING DRUG Manufacturing (CMC) Approval
06/24/2020 AMMONIA N 13
ANDA #203779		 SUPPL-1 AMMONIA N-13 3D IMAGING DRUG Manufacturing (CMC) Approval
06/24/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205867		 SUPPL-1 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
06/24/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205867		 SUPPL-2 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
06/24/2020 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205867		 SUPPL-4 DEXMEDETOMIDINE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
06/24/2020 PRASUGREL
ANDA #205927		 SUPPL-3 PRASUGREL HYDROCHLORIDE MYLAN Labeling Approval
06/24/2020 PITAVASTATIN CALCIUM
ANDA #206015		 SUPPL-3 PITAVASTATIN CALCIUM AUROBINDO PHARMA Labeling Approval
06/24/2020 PITAVASTATIN CALCIUM
ANDA #206015		 SUPPL-4 PITAVASTATIN CALCIUM AUROBINDO PHARMA Labeling Approval
06/24/2020 SUMATRIPTAN AND NAPROXEN SODIUM
ANDA #207457		 SUPPL-6 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE AUROBINDO PHARMA LTD Labeling Approval
06/24/2020 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #211876		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE AUROLIFE PHARMA LLC Approval
06/24/2020 DRIZALMA SPRINKLE
NDA #212516		 SUPPL-1 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
06/24/2020 PREDNISONE
ANDA #213386		 ORIG-1 PREDNISONE AMNEAL Approval
06/24/2020 ASPARLAS
BLA #761102		 SUPPL-3 CALASPARGASE PEGOL-MKNL SERVIER PHARMA LLC Approval
06/25/2020 HALOPERIDOL DECANOATE
ANDA #075393		 SUPPL-33 HALOPERIDOL DECANOATE TEVA PHARMS USA Labeling Approval
06/25/2020 NITROGLYCERIN
ANDA #087355		 SUPPL-33 NITROGLYCERIN FOUGERA PHARMS INC Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-8 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-9 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-10 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-11 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-12 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-13 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-14 DIVALPROEX SODIUM RISING Labeling Approval
06/25/2020 ROCURONIUM BROMIDE
ANDA #091458		 SUPPL-13 ROCURONIUM BROMIDE SAGENT PHARMS INC Labeling Approval
06/25/2020 SUMATRIPTAN SUCCINATE
ANDA #200263		 SUPPL-1 SUMATRIPTAN SUCCINATE COREPHARMA Labeling Approval
06/25/2020 TRANEXAMIC ACID
ANDA #201580		 SUPPL-3 TRANEXAMIC ACID XGEN PHARMS Labeling Approval
06/25/2020 ACITRETIN
ANDA #202148		 SUPPL-3 ACITRETIN MYLAN Labeling Approval
06/25/2020 PROCHLORPERAZINE EDISYLATE
ANDA #204147		 SUPPL-25 PROCHLORPERAZINE EDISYLATE AVET LIFESCIENCES Labeling Approval
06/25/2020 AMOXICILLIN
ANDA #205274		 ORIG-1 AMOXICILLIN HIKMA Approval
06/25/2020 ESOMEPRAZOLE MAGNESIUM
ANDA #212088		 ORIG-1 ESOMEPRAZOLE MAGNESIUM MYLAN Approval
06/25/2020 FINTEPLA
NDA #212102		 ORIG-1 FENFLURAMINE HYDROCHLORIDE UCB INC Type 3 - New Dosage Form Approval
06/25/2020 PROPAFENONE HYDROCHLORIDE
ANDA #212744		 ORIG-1 PROPAFENONE HYDROCHLORIDE UPSHER SMITH LABS Approval
06/25/2020 LIBTAYO
BLA #761097		 SUPPL-5 CEMIPLIMAB-RWLC REGENERON PHARMACEUTICALS Approval
06/26/2020 FRAGMIN
NDA #020287		 SUPPL-74 DALTEPARIN SODIUM PFIZER Labeling Approval
06/26/2020 FRAGMIN
NDA #020287		 SUPPL-75 DALTEPARIN SODIUM PFIZER Labeling Approval
06/26/2020 LIALDA
NDA #022000		 SUPPL-19 MESALAMINE TAKEDA PHARMS USA Efficacy Approval
06/26/2020 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #203263		 SUPPL-27 DOXORUBICIN HYDROCHLORIDE SUN PHARM Labeling Approval
06/26/2020 CYTARABINE
ANDA #206189		 ORIG-1 CYTARABINE MEITHEAL Approval
06/26/2020 MYCAPSSA
NDA #208232		 ORIG-1 OCTREOTIDE ACETATE CHIESI Type 5 - New Formulation or New Manufacturer Approval
06/26/2020 DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #208657		 SUPPL-4 DOXORUBICIN HYDROCHLORIDE DR REDDYS Labeling Approval
06/26/2020 GAMIFANT
BLA #761107		 SUPPL-4 EMAPALUMAB-LZSG NOVIMMUNE S.A. Approval
06/27/2020 HELIUM, USP
NDA #214937		 ORIG-1 HELIUM WESTAIR GASES & EQUIPMENT INC Approval
06/29/2020 CARDIZEM
NDA #018602		 SUPPL-69 DILTIAZEM HYDROCHLORIDE BAUSCH Manufacturing (CMC) Approval
06/29/2020 DACOGEN
NDA #021790		 SUPPL-25 DECITABINE OTSUKA Labeling Approval
06/29/2020 NEVIRAPINE
ANDA #078644		 SUPPL-3 NEVIRAPINE PRINSTON INC Labeling Approval
06/29/2020 NEVIRAPINE
ANDA #078644		 SUPPL-5 NEVIRAPINE PRINSTON INC Labeling Approval
06/29/2020 CAMPATH
BLA #103948		 SUPPL-5176 ALEMTUZUMAB GENZYME Approval
06/29/2020 LEMTRADA
BLA #103948		 SUPPL-5176 ALEMTUZUMAB GENZYME Approval
06/29/2020 YERVOY
BLA #125377		 SUPPL-106 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
06/29/2020 KEYTRUDA
BLA #125514		 SUPPL-84 PEMBROLIZUMAB MERCK SHARP DOHME Approval
06/29/2020 GRANISETRON HYDROCHLORIDE
ANDA #202648		 ORIG-1 GRANISETRON HYDROCHLORIDE YUNG SHIN PHARM Approval
06/29/2020 FINGOLIMOD HYDROCHLORIDE
ANDA #207971		 ORIG-1 FINGOLIMOD HYDROCHLORIDE CHARTWELL RX Approval
06/29/2020 POTASSIUM CITRATE
ANDA #212799		 ORIG-1 POTASSIUM CITRATE BIONPHARMA Approval
06/29/2020 Nitrogen, NF
NDA #214858		 ORIG-1 Nitrogen AIR LIQUIDE CANADA INC Approval
06/29/2020 DARZALEX
BLA #761036		 SUPPL-26 DARATUMUMAB JANSSEN BIOTECH Approval
06/29/2020 PHESGO
BLA #761170		 ORIG-1 PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF GENENTECH INC Approval
06/30/2020 FORTESTA
NDA #021463		 SUPPL-25 TESTOSTERONE ENDO OPERATIONS Labeling Approval
06/30/2020 AVEED
NDA #022219		 SUPPL-14 TESTOSTERONE UNDECANOATE ENDO OPERATIONS Labeling Approval
06/30/2020 VALSARTAN
ANDA #090642		 SUPPL-5 VALSARTAN WATSON LABS INC Labeling Approval
06/30/2020 VALSARTAN
ANDA #090642		 SUPPL-7 VALSARTAN WATSON LABS INC Labeling Approval
06/30/2020 RETACRIT
BLA #125545		 SUPPL-5 EPOETIN ALFA-EPBX HOSPIRA INC Approval
06/30/2020 VALSARTAN
ANDA #202728		 SUPPL-6 VALSARTAN TORRENT Labeling Approval
06/30/2020 VALSARTAN
ANDA #202728		 SUPPL-7 VALSARTAN TORRENT Labeling Approval
06/30/2020 BUPROPION HYDROCHLORIDE
ANDA #206556		 SUPPL-14 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/30/2020 BUPROPION HYDROCHLORIDE
ANDA #207479		 SUPPL-2 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
06/30/2020 BUPROPION HYDROCHLORIDE
ANDA #207479		 SUPPL-10 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
06/30/2020 BUPROPION HYDROCHLORIDE
ANDA #208652		 SUPPL-5 BUPROPION HYDROCHLORIDE SINOTHERAPEUTICS INC Labeling Approval
06/30/2020 BUPROPION HYDROCHLORIDE
ANDA #211020		 SUPPL-4 BUPROPION HYDROCHLORIDE GRAVITI PHARMS Labeling Approval
06/30/2020 DOXYCYCLINE HYCLATE
ANDA #211744		 ORIG-1 DOXYCYCLINE HYCLATE ALEMBIC Approval
06/30/2020 DOJOLVI
NDA #213687		 ORIG-1 TRIHEPTANOIN ULTRAGENYX PHARM INC Type 1 - New Molecular Entity Approval
06/30/2020 PANTOPRAZOLE SODIUM
ANDA #213725		 ORIG-1 PANTOPRAZOLE SODIUM SUN PHARM Approval
06/30/2020 BAVENCIO
BLA #761049		 SUPPL-9 AVELUMAB EMD SERONO INC Approval
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