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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 2021

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
11/01/2021 AZULFIDINE
NDA #007073		 SUPPL-130 SULFASALAZINE PFIZER Labeling Approval
11/01/2021 AZULFIDINE EN-TABS
NDA #007073		 SUPPL-130 SULFASALAZINE PFIZER Labeling Approval
11/01/2021 ROWASA
NDA #019618		 SUPPL-29 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
11/01/2021 SFROWASA
NDA #019618		 SUPPL-29 MESALAMINE MYLAN SPECIALITY LP Labeling Approval
11/01/2021 DIPENTUM
NDA #019715		 SUPPL-30 OLSALAZINE SODIUM MYLAN SPCLT VIATRIS Labeling Approval
11/01/2021 PENTASA
NDA #020049		 SUPPL-36 MESALAMINE TAKEDA PHARMS USA Labeling Approval
11/01/2021 COLAZAL
NDA #020610		 SUPPL-24 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
11/01/2021 CANASA
NDA #021252		 SUPPL-28 MESALAMINE ABBVIE Labeling Approval
11/01/2021 FINACEA
NDA #021470		 SUPPL-17 AZELAIC ACID LEO PHARMA AS Labeling Approval
11/01/2021 ASACOL HD
NDA #021830		 SUPPL-19 MESALAMINE ABBVIE Labeling Approval
11/01/2021 LIALDA
NDA #022000		 SUPPL-23 MESALAMINE TAKEDA PHARMS USA Labeling Approval
11/01/2021 GIAZO
NDA #022205		 SUPPL-5 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
11/01/2021 APRISO
NDA #022301		 SUPPL-18 MESALAMINE SALIX Labeling Approval
11/01/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #202842		 SUPPL-8 DEXMETHYLPHENIDATE HYDROCHLORIDE PAR PHARM INC Labeling Approval
11/01/2021 DELZICOL
NDA #204412		 SUPPL-15 MESALAMINE ABBVIE Labeling Approval
11/01/2021 SAVAYSA
NDA #206316		 SUPPL-18 EDOXABAN TOSYLATE DAIICHI SANKYO INC Labeling Approval
11/01/2021 QUETIAPINE FUMARATE
ANDA #207655		 SUPPL-5 QUETIAPINE FUMARATE AUROBINDO PHARMA Labeling Approval
11/01/2021 QUETIAPINE FUMARATE
ANDA #207655		 SUPPL-6 QUETIAPINE FUMARATE AUROBINDO PHARMA Labeling Approval
11/01/2021 QUETIAPINE FUMARATE
ANDA #207655		 SUPPL-7 QUETIAPINE FUMARATE AUROBINDO PHARMA Labeling Approval
11/01/2021 ACYCLOVIR
ANDA #208766		 SUPPL-2 ACYCLOVIR AMNEAL Labeling Approval
11/01/2021 ASTEPRO ALLERGY
NDA #213872		 SUPPL-1 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
11/01/2021 CHILDREN'S ASTEPRO ALLERGY
NDA #213872		 SUPPL-1 AZELASTINE HYDROCHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
11/01/2021 DROXIDOPA
ANDA #215265		 ORIG-1 DROXIDOPA SLATE RUN PHARMA Approval
11/02/2021 VYVANSE
NDA #021977		 SUPPL-47 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
11/02/2021 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-14 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/02/2021 ZIPRASIDONE HYDROCHLORIDE
ANDA #077565		 SUPPL-18 ZIPRASIDONE HYDROCHLORIDE DR REDDYS LABS INC Labeling Approval
11/02/2021 DISULFIRAM
ANDA #091563		 SUPPL-7 DISULFIRAM CHARTWELL MOLECULES Manufacturing (CMC) Approval
11/02/2021 ONCASPAR
BLA #103411		 SUPPL-5201 PEGASPARGASE SIGMA TAU Approval
11/02/2021 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-9 QUETIAPINE FUMARATE UNICHEM Labeling Approval
11/02/2021 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-11 QUETIAPINE FUMARATE UNICHEM Labeling Approval
11/02/2021 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-12 QUETIAPINE FUMARATE UNICHEM Labeling Approval
11/02/2021 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-13 QUETIAPINE FUMARATE UNICHEM Labeling Approval
11/02/2021 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-16 QUETIAPINE FUMARATE UNICHEM Labeling Approval
11/02/2021 VYVANSE
NDA #208510		 SUPPL-4 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
11/02/2021 ACYCLOVIR
ANDA #208702		 SUPPL-2 ACYCLOVIR PADAGIS ISRAEL Labeling Approval
11/02/2021 PAROXETINE HYDROCHLORIDE
ANDA #211248		 ORIG-1 PAROXETINE HYDROCHLORIDE YILING Approval
11/02/2021 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #211476		 ORIG-1 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE TEVA PHARMS USA Approval
11/02/2021 LEVOLEUCOVORIN CALCIUM
ANDA #213797		 ORIG-1 LEVOLEUCOVORIN CALCIUM AILEX PHARMS LLC Approval
11/02/2021 VALSARTAN
ANDA #214102		 ORIG-1 VALSARTAN NOVITIUM PHARMA Approval
11/02/2021 MYCOPHENOLATE MOFETIL
ANDA #214871		 ORIG-1 MYCOPHENOLATE MOFETIL AMNEAL Approval
11/03/2021 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019632		 SUPPL-50 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
11/03/2021 DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
11/03/2021 DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
11/03/2021 DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019634		 SUPPL-50 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE B BRAUN Labeling Approval
11/03/2021 RINGER'S IN PLASTIC CONTAINER
NDA #020002		 SUPPL-32 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE B BRAUN Labeling Approval
11/03/2021 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-38 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Labeling Approval
11/03/2021 ZYRTEC-D 12 HOUR
NDA #021150		 SUPPL-21 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
11/03/2021 CITANEST FORTE DENTAL
NDA #021383		 SUPPL-10 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
11/03/2021 ROZEREM
NDA #021782		 SUPPL-22 RAMELTEON TAKEDA PHARMS USA Labeling Approval
11/03/2021 VOLTAREN ARTHRITIS PAIN
NDA #022122		 SUPPL-18 DICLOFENAC SODIUM HALEON US HOLDINGS Labeling Approval
11/03/2021 FLECAINIDE ACETATE
ANDA #075882		 SUPPL-13 FLECAINIDE ACETATE ANI PHARMS Manufacturing (CMC) Approval
11/03/2021 BETASERON
BLA #103471		 SUPPL-5200 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
11/03/2021 AVONEX
BLA #103628		 SUPPL-5266 INTERFERON BETA-1A BIOGEN Approval
11/03/2021 REBIF
BLA #103780		 SUPPL-5210 INTERFERON BETA-1A SERONO INC Approval
11/03/2021 PLEGRIDY
BLA #125499		 SUPPL-23 PEGINTERFERON BETA-1A BIOGEN IDEC INC Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-3 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-5 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-6 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-7 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-8 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-9 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-11 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 OLANZAPINE
ANDA #203708		 SUPPL-13 OLANZAPINE AUROBINDO PHARMA LTD Labeling Approval
11/03/2021 ISOSULFAN BLUE
ANDA #213130		 ORIG-1 ISOSULFAN BLUE MEITHEAL Approval
11/03/2021 GATIFLOXACIN
ANDA #213542		 ORIG-1 GATIFLOXACIN TORRENT Approval
11/03/2021 MYCOPHENOLIC SODIUM
ANDA #214289		 ORIG-1 MYCOPHENOLIC SODIUM TWI PHARMS Approval
11/03/2021 FAMOTIDINE
ANDA #216030		 ORIG-1 FAMOTIDINE ASCENT PHARMS INC Approval
11/04/2021 VELCADE
NDA #021602		 SUPPL-46 BORTEZOMIB TAKEDA PHARMS USA Labeling Approval
11/04/2021 BYETTA
NDA #021773		 SUPPL-45 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
11/04/2021 SALONPAS
NDA #022029		 SUPPL-19 MENTHOL; METHYL SALICYLATE HISAMITSU PHARM CO Labeling Approval
11/04/2021 JANUMET
NDA #022044		 SUPPL-51 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
11/04/2021 JANUMET XR
NDA #202270		 SUPPL-25 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
11/04/2021 DYANAVEL XR 10
NDA #210526		 ORIG-1 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Type 3 - New Dosage Form Approval
11/04/2021 DYANAVEL XR 15
NDA #210526		 ORIG-1 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Type 3 - New Dosage Form Approval
11/04/2021 DYANAVEL XR 20
NDA #210526		 ORIG-1 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Type 3 - New Dosage Form Approval
11/04/2021 DYANAVEL XR 5
NDA #210526		 ORIG-1 AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE TRIS PHARMA INC Type 3 - New Dosage Form Approval
11/04/2021 YUPELRI
NDA #210598		 SUPPL-2 REVEFENACIN MYLAN IRELAND LTD Labeling Approval
11/04/2021 HYDROCORTISONE VALERATE
ANDA #211047		 ORIG-1 HYDROCORTISONE VALERATE ENCUBE ETHICALS Approval
11/04/2021 PREGABALIN
ANDA #211967		 ORIG-1 PREGABALIN MYLAN Approval
11/04/2021 YUTREPIA
NDA #213005		 ORIG-1 TREPROSTINIL Liquidia Technologies, Inc. Type 3 - New Dosage Form Tentative Approval
11/04/2021 TADALAFIL
ANDA #215556		 ORIG-1 TADALAFIL VKT PHARMA Approval
11/04/2021 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #215562		 ORIG-1 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE NOVITIUM PHARMA Approval
11/04/2021 FAMOTIDINE
ANDA #215767		 ORIG-1 FAMOTIDINE ANNORA PHARMA Approval
11/05/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206734		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Approval
11/05/2021 ROZLYTREK
NDA #212725		 SUPPL-5 ENTRECTINIB GENENTECH INC Labeling Approval
11/05/2021 EPRONTIA
NDA #214679		 ORIG-1 TOPIRAMATE AZURITY Type 3 - New Dosage Form Approval
11/08/2021 AMNESTEEM
ANDA #075945		 SUPPL-41 ISOTRETINOIN MYLAN PHARMS INC Labeling Approval
11/08/2021 CLARAVIS
ANDA #076135		 SUPPL-53 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
11/08/2021 CLARAVIS
ANDA #076356		 SUPPL-48 ISOTRETINOIN TEVA PHARMS USA Labeling Approval
11/08/2021 MYORISAN
ANDA #076485		 SUPPL-28 ISOTRETINOIN UPSHER SMITH LABS Labeling Approval
11/08/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #200837		 SUPPL-12 VANCOMYCIN HYDROCHLORIDE SAGENT PHARMS Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #201749		 SUPPL-3 METHOTREXATE SODIUM SUN PHARM Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #201749		 SUPPL-6 METHOTREXATE SODIUM SUN PHARM Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #201749		 SUPPL-10 METHOTREXATE SODIUM SUN PHARM Labeling Approval
11/08/2021 AZTREONAM
ANDA #206517		 ORIG-1 AZTREONAM HOSPIRA Approval
11/08/2021 TRANEXAMIC ACID
ANDA #206594		 SUPPL-4 TRANEXAMIC ACID EPIC PHARMA LLC Labeling Approval
11/08/2021 ISOTRETINOIN
ANDA #207792		 SUPPL-15 ISOTRETINOIN AMNEAL PHARMS NY Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #207812		 SUPPL-2 METHOTREXATE SODIUM ZYDUS PHARMS Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #207812		 SUPPL-4 METHOTREXATE SODIUM ZYDUS PHARMS Labeling Approval
11/08/2021 CLOBAZAM
ANDA #208825		 SUPPL-2 CLOBAZAM BIONPHARMA Labeling Approval
11/08/2021 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #209642		 ORIG-1 MAGNESIUM SULFATE MILLA PHARMS Approval
11/08/2021 CLOBAZAM
ANDA #209687		 SUPPL-5 CLOBAZAM UPSHER SMITH LABS Labeling Approval
11/08/2021 CLOBAZAM
ANDA #211959		 SUPPL-1 CLOBAZAM CELLTRION Labeling Approval
11/08/2021 CLOBAZAM
ANDA #212398		 SUPPL-1 CLOBAZAM ACCORD HLTHCARE Labeling Approval
11/08/2021 METHOTREXATE SODIUM
ANDA #213343		 SUPPL-1 METHOTREXATE SODIUM ACCORD HLTHCARE Labeling Approval
11/08/2021 METOPROLOL SUCCINATE
ANDA #213854		 SUPPL-1 METOPROLOL SUCCINATE YICHANG HUMANWELL Manufacturing (CMC) Approval
11/08/2021 LIDOCAINE HYDROCHLORIDE
ANDA #214336		 ORIG-1 LIDOCAINE HYDROCHLORIDE ASPIRO Approval
11/08/2021 LIDOCAINE HYDROCHLORIDE
ANDA #214339		 ORIG-1 LIDOCAINE HYDROCHLORIDE ASPIRO Approval
11/08/2021 LINCOMYCIN HYDROCHLORIDE
ANDA #215082		 ORIG-1 LINCOMYCIN HYDROCHLORIDE MICRO LABS Approval
11/08/2021 FAMOTIDINE
ANDA #215766		 ORIG-1 FAMOTIDINE ANNORA PHARMA Approval
11/09/2021 PRINIVIL
NDA #019558		 SUPPL-63 LISINOPRIL MERCK Labeling Approval
11/09/2021 PROCARDIA XL
NDA #019684		 SUPPL-33 NIFEDIPINE PFIZER Labeling Approval
11/09/2021 NICORETTE
NDA #021330		 SUPPL-24 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
11/09/2021 DIAZEPAM
ANDA #070313		 SUPPL-25 DIAZEPAM HIKMA Labeling Approval
11/09/2021 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #076629		 SUPPL-10 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE DR REDDYS LABS SA Labeling Approval
11/09/2021 MEMANTINE HYDROCHLORIDE
ANDA #200155		 SUPPL-1 MEMANTINE HYDROCHLORIDE TORRENT Labeling Approval
11/09/2021 ARFORMOTEROL TARTRATE
ANDA #200293		 ORIG-1 ARFORMOTEROL TARTRATE TEVA PHARMS USA Approval
11/09/2021 LAMOTRIGINE
ANDA #201791		 SUPPL-8 LAMOTRIGINE PAR PHARM Labeling Approval
11/09/2021 ZENATANE
ANDA #202099		 SUPPL-23 ISOTRETINOIN DR REDDYS LABS LTD Labeling Approval
11/09/2021 TRANEXAMIC ACID
ANDA #202373		 SUPPL-2 TRANEXAMIC ACID EPIC PHARMA LLC Labeling Approval
11/09/2021 LAMOTRIGINE
ANDA #202383		 SUPPL-12 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
11/09/2021 LAMOTRIGINE
ANDA #202383		 SUPPL-13 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
11/09/2021 QUETIAPINE FUMARATE
ANDA #203150		 SUPPL-3 QUETIAPINE FUMARATE JUBILANT GENERICS Labeling Approval
11/09/2021 QUETIAPINE FUMARATE
ANDA #203150		 SUPPL-8 QUETIAPINE FUMARATE JUBILANT GENERICS Labeling Approval
11/09/2021 QUETIAPINE FUMARATE
ANDA #203150		 SUPPL-10 QUETIAPINE FUMARATE JUBILANT GENERICS Labeling Approval
11/09/2021 QUETIAPINE FUMARATE
ANDA #203359		 SUPPL-14 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
11/09/2021 QUETIAPINE FUMARATE
ANDA #203359		 SUPPL-15 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
11/09/2021 LAMOTRIGINE
ANDA #203370		 SUPPL-13 LAMOTRIGINE TORRENT Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-2 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-5 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-6 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-7 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-10 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 LANSOPRAZOLE
ANDA #203957		 SUPPL-12 LANSOPRAZOLE AJANTA PHARMA LTD Labeling Approval
11/09/2021 TRANEXAMIC ACID
ANDA #209860		 SUPPL-1 TRANEXAMIC ACID APOTEX Labeling Approval
11/09/2021 TRANEXAMIC ACID
ANDA #209860		 SUPPL-2 TRANEXAMIC ACID APOTEX Labeling Approval
11/09/2021 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
ANDA #211428		 ORIG-1 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS KABI USA Approval
11/09/2021 TESTOSTERONE
ANDA #212984		 ORIG-1 TESTOSTERONE ENCUBE Approval
11/09/2021 GLYCOPYRROLATE
ANDA #214213		 ORIG-1 GLYCOPYRROLATE ZYDUS PHARMS Approval
11/10/2021 CLOZARIL
NDA #019758		 SUPPL-99 CLOZAPINE HERITAGE LIFE REMS Approval
11/10/2021 EFFEXOR XR
NDA #020699		 SUPPL-113 VENLAFAXINE HYDROCHLORIDE UPJOHN Labeling Approval
11/10/2021 ZYVOX
NDA #021131		 SUPPL-40 LINEZOLID PFIZER Labeling Approval
11/10/2021 PRISTIQ
NDA #021992		 SUPPL-47 DESVENLAFAXINE SUCCINATE PF PRISM CV Labeling Approval
11/10/2021 DIAZEPAM
ANDA #070312		 SUPPL-18 DIAZEPAM HIKMA Labeling Approval
11/10/2021 CLOZAPINE
ANDA #074949		 SUPPL-86 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
11/10/2021 MIDAZOLAM HYDROCHLORIDE
ANDA #075243		 SUPPL-36 MIDAZOLAM HYDROCHLORIDE HIKMA Labeling Approval
11/10/2021 CLOZAPINE
ANDA #075417		 SUPPL-51 CLOZAPINE MYLAN REMS Approval
11/10/2021 CLOZAPINE
ANDA #075713		 SUPPL-55 CLOZAPINE SUN PHARM INDS INC REMS Approval
11/10/2021 CLOZAPINE
ANDA #076809		 SUPPL-49 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
11/10/2021 CLOZAPINE
ANDA #090308		 SUPPL-11 CLOZAPINE BARR LABS INC REMS Approval
11/10/2021 CLOZAPINE
ANDA #201824		 SUPPL-16 CLOZAPINE MYLAN REMS Approval
11/10/2021 LEVETIRACETAM
ANDA #202095		 SUPPL-3 LEVETIRACETAM LOTUS PHARM CO LTD Labeling Approval
11/10/2021 LEVETIRACETAM
ANDA #202095		 SUPPL-5 LEVETIRACETAM LOTUS PHARM CO LTD Labeling Approval
11/10/2021 LEVETIRACETAM
ANDA #202095		 SUPPL-7 LEVETIRACETAM LOTUS PHARM CO LTD Labeling Approval
11/10/2021 LEVETIRACETAM
ANDA #202095		 SUPPL-8 LEVETIRACETAM LOTUS PHARM CO LTD Labeling Approval
11/10/2021 CLOZAPINE
ANDA #202873		 SUPPL-11 CLOZAPINE ACCORD HLTHCARE REMS Approval
11/10/2021 CLOZAPINE
ANDA #203039		 SUPPL-12 CLOZAPINE TEVA PHARMS USA REMS Approval
11/10/2021 VERSACLOZ
NDA #203479		 SUPPL-17 CLOZAPINE TASMAN PHARMA REMS Approval
11/10/2021 CLOZAPINE
ANDA #203807		 SUPPL-14 CLOZAPINE DR REDDYS LABS SA REMS Approval
11/10/2021 CLOZAPINE
ANDA #206433		 SUPPL-13 CLOZAPINE AUROBINDO PHARMA REMS Approval
11/10/2021 FINGOLIMOD HYDROCHLORIDE
ANDA #207939		 ORIG-1 FINGOLIMOD HYDROCHLORIDE HEC PHARM CO LTD Approval
11/10/2021 ENTECAVIR
ANDA #208195		 ORIG-1 ENTECAVIR YUNG SHIN PHARM Approval
11/10/2021 CALCITONIN-SALMON
ANDA #209358		 ORIG-1 CALCITONIN SALMON PAR STERILE PRODUCTS Approval
11/10/2021 LEVOCARNITINE
ANDA #212533		 ORIG-1 LEVOCARNITINE SAPTALIS PHARMS Approval
11/10/2021 ELUXADOLINE
ANDA #213522		 ORIG-1 ELUXADOLINE ZYDUS PHARMS USA INC Tentative Approval
11/10/2021 GAVRETO
NDA #213721		 SUPPL-4 PRALSETINIB BLUEPRINT MEDICINES Labeling Approval
11/11/2021 CIPRO
NDA #019537		 SUPPL-92 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
11/12/2021 LUPRON DEPOT-PED KIT
NDA #020263		 SUPPL-48 LEUPROLIDE ACETATE ABBVIE ENDOCRINE INC Labeling Approval
11/12/2021 DIAZEPAM
ANDA #070311		 SUPPL-22 DIAZEPAM HIKMA Labeling Approval
11/12/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #201048		 SUPPL-1 VANCOMYCIN HYDROCHLORIDE SANDOZ INC Labeling Approval
11/12/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #201048		 SUPPL-2 VANCOMYCIN HYDROCHLORIDE SANDOZ INC Labeling Approval
11/12/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #201048		 SUPPL-3 VANCOMYCIN HYDROCHLORIDE SANDOZ INC Labeling Approval
11/12/2021 DOXEPIN HYDROCHLORIDE
ANDA #202337		 SUPPL-4 DOXEPIN HYDROCHLORIDE RK PHARMA Labeling Approval
11/12/2021 LANSOPRAZOLE
ANDA #202396		 SUPPL-2 LANSOPRAZOLE MYLAN Labeling Approval
11/12/2021 LANSOPRAZOLE
ANDA #203083		 SUPPL-1 LANSOPRAZOLE HETERO LABS LTD III Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-4 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-6 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-7 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-9 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-11 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 QUETIAPINE FUMARATE
ANDA #204203		 SUPPL-13 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
11/12/2021 PALONOSETRON HYDROCHLORIDE
ANDA #206916		 ORIG-1 PALONOSETRON HYDROCHLORIDE BAXTER HLTHCARE CORP Approval
11/12/2021 NAFTIFINE HYDROCHLORIDE
ANDA #208201		 SUPPL-3 NAFTIFINE HYDROCHLORIDE TARO Labeling Approval
11/12/2021 CLOBAZAM
ANDA #208819		 SUPPL-5 CLOBAZAM BIONPHARMA Labeling Approval
11/12/2021 HALOPERIDOL DECANOATE
ANDA #209101		 SUPPL-5 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
11/12/2021 HALOPERIDOL DECANOATE
ANDA #209101		 SUPPL-6 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
11/12/2021 HALOPERIDOL DECANOATE
ANDA #209101		 SUPPL-7 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
11/12/2021 HALOPERIDOL DECANOATE
ANDA #209101		 SUPPL-8 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
11/12/2021 HALOPERIDOL DECANOATE
ANDA #209101		 SUPPL-11 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Labeling Approval
11/12/2021 NEOSTIGMINE METHYLSULFATE
ANDA #209182		 SUPPL-3 NEOSTIGMINE METHYLSULFATE AM REGENT Labeling Approval
11/12/2021 MEFENAMIC ACID
ANDA #209209		 SUPPL-1 MEFENAMIC ACID CHARTWELL RX Labeling Approval
11/12/2021 ABIRATERONE ACETATE
ANDA #209227		 SUPPL-3 ABIRATERONE ACETATE GLENMARK PHARMS Labeling Approval
11/12/2021 GABAPENTIN
ANDA #209306		 SUPPL-2 GABAPENTIN LUPIN LTD Labeling Approval
11/12/2021 GABAPENTIN
ANDA #209306		 SUPPL-3 GABAPENTIN LUPIN LTD Labeling Approval
11/12/2021 ARSENIC TRIOXIDE
ANDA #209315		 SUPPL-5 ARSENIC TRIOXIDE INGENUS PHARMS LLC Labeling Approval
11/12/2021 FETROJA
NDA #209445		 SUPPL-4 CEFIDEROCOL SULFATE TOSYLATE SHIONOGI INC Labeling Approval
11/12/2021 FULVESTRANT
NDA #210063		 SUPPL-3 FULVESTRANT TEVA PHARMS USA INC Labeling Approval
11/12/2021 CLOBAZAM
ANDA #211711		 SUPPL-3 CLOBAZAM MICRO LABS Labeling Approval
11/12/2021 FINGOLIMOD HYDROCHLORIDE
ANDA #212152		 ORIG-1 FINGOLIMOD HYDROCHLORIDE TEVA PHARMS USA Approval
11/12/2021 NITAZOXANIDE
ANDA #213820		 SUPPL-1 NITAZOXANIDE RISING Manufacturing (CMC) Approval
11/12/2021 DHIVY
NDA #214869		 ORIG-1 CARBIDOPA; LEVODOPA AVION PHARMS Type 5 - New Formulation or New Manufacturer Approval
11/12/2021 BENDAMUSTINE HYDROCHLORIDE
NDA #215668		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE DR REDDYS LABS LTD Type 5 - New Formulation or New Manufacturer Tentative Approval
11/12/2021 BESREMI
BLA #761166		 ORIG-1 ROPEGINTERFERON ALFA-2B-NJFT PHARMAESSENTIA CORP Approval
11/14/2021 LANSOPRAZOLE
ANDA #200816		 SUPPL-1 LANSOPRAZOLE ZYDUS PHARMS Labeling Approval
11/14/2021 LANSOPRAZOLE
ANDA #200816		 SUPPL-2 LANSOPRAZOLE ZYDUS PHARMS Labeling Approval
11/15/2021 MICRONOR
NDA #016954		 SUPPL-100 NORETHINDRONE JANSSEN PHARMS Labeling Approval
11/15/2021 MICRONOR
NDA #016954		 SUPPL-108 NORETHINDRONE JANSSEN PHARMS Labeling Approval
11/15/2021 CLIMARA PRO
NDA #021258		 SUPPL-12 ESTRADIOL; LEVONORGESTREL BAYER HLTHCARE Labeling Approval
11/15/2021 AZITHROMYCIN
ANDA #065150		 SUPPL-19 AZITHROMYCIN TEVA Labeling Approval
11/15/2021 AZITHROMYCIN
ANDA #065360		 SUPPL-9 AZITHROMYCIN AUROBINDO PHARMA USA Labeling Approval
11/15/2021 RYDAPT
NDA #207997		 SUPPL-8 MIDOSTAURIN NOVARTIS Labeling Approval
11/15/2021 CLOBAZAM
ANDA #208785		 SUPPL-1 CLOBAZAM HIKMA Labeling Approval
11/15/2021 ACYCLOVIR
ANDA #212202		 ORIG-1 ACYCLOVIR PRINSTON INC Approval
11/15/2021 OMEGA-3-ACID ETHYL ESTERS
ANDA #215458		 ORIG-1 OMEGA-3-ACID ETHYL ESTERS MANKIND PHARMA Approval
11/15/2021 MVASI
BLA #761028		 SUPPL-8 BEVACIZUMAB-AWWB AMGEN INC Approval
11/15/2021 RUXIENCE
BLA #761103		 SUPPL-5 RITUXIMAB-PVVR PFIZER INC Approval
11/16/2021 MOTRIN IB
NDA #019012		 SUPPL-59 IBUPROFEN J AND J CONSUMER INC Labeling Approval
11/16/2021 MOTRIN MIGRAINE PAIN
NDA #019012		 SUPPL-59 IBUPROFEN J AND J CONSUMER INC Labeling Approval
11/16/2021 NUPRIN
NDA #019012		 SUPPL-59 IBUPROFEN J AND J CONSUMER INC Labeling Approval
11/16/2021 FENOFIBRIC ACID
ANDA #200913		 SUPPL-7 CHOLINE FENOFIBRATE MYLAN PHARMS INC Labeling Approval
11/16/2021 FENOFIBRATE (MICRONIZED)
ANDA #202252		 SUPPL-9 FENOFIBRATE APOTEX Labeling Approval
11/16/2021 PALIPERIDONE
ANDA #202645		 SUPPL-13 PALIPERIDONE ACTAVIS LABS FL INC Labeling Approval
11/16/2021 OLOPATADINE HYDROCHLORIDE
ANDA #202853		 SUPPL-11 OLOPATADINE HYDROCHLORIDE PADAGIS ISRAEL Labeling Approval
11/16/2021 MOXIFLOXACIN HYDROCHLORIDE
ANDA #202916		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203059		 SUPPL-22 LEVETIRACETAM SUN PHARM Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-1 LEVETIRACETAM PRINSTON INC Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-3 LEVETIRACETAM PRINSTON INC Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-5 LEVETIRACETAM PRINSTON INC Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-6 LEVETIRACETAM PRINSTON INC Labeling Approval
11/16/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-8 LEVETIRACETAM PRINSTON INC Labeling Approval
11/16/2021 VAZALORE
NDA #203697		 SUPPL-8 ASPIRIN PLX PHARMA Labeling Approval
11/16/2021 METOPROLOL TARTRATE
ANDA #204205		 SUPPL-4 METOPROLOL TARTRATE GLAND PHARMA LTD Labeling Approval
11/16/2021 DUTASTERIDE
ANDA #204262		 SUPPL-9 DUTASTERIDE STRIDES PHARMA Labeling Approval
11/16/2021 BUDESONIDE
ANDA #205710		 SUPPL-17 BUDESONIDE CIPLA Labeling Approval
11/16/2021 IMVEXXY
NDA #208564		 SUPPL-2 ESTRADIOL MAYNE PHARMA Labeling Approval
11/16/2021 ASPIRIN AND DIPYRIDAMOLE
ANDA #210318		 SUPPL-3 ASPIRIN; DIPYRIDAMOLE GLENMARK PHARMS SA Labeling Approval
11/16/2021 MUPIROCIN
ANDA #213053		 ORIG-1 MUPIROCIN CALCIUM ALEMBIC Approval
11/16/2021 TIAGABINE HYDROCHLORIDE
ANDA #214816		 ORIG-1 TIAGABINE HYDROCHLORIDE MSN Approval
11/16/2021 SILDENAFIL CITRATE
ANDA #215522		 ORIG-1 SILDENAFIL CITRATE TARO Approval
11/16/2021 PREDNISONE
ANDA #215671		 ORIG-1 PREDNISONE AUROBINDO PHARMA LTD Approval
11/17/2021 TIMOPTIC
NDA #018086		 SUPPL-80 TIMOLOL MALEATE BAUSCH AND LOMB INC Labeling Approval
11/17/2021 AROMASIN
NDA #020753		 SUPPL-22 EXEMESTANE PFIZER Labeling Approval
11/17/2021 FLUORESCITE
NDA #021980		 SUPPL-7 FLUORESCEIN SODIUM ALCON LABS INC Labeling Approval
11/17/2021 AZASITE
NDA #050810		 SUPPL-19 AZITHROMYCIN THEA PHARMA Labeling Approval
11/17/2021 CHLORHEXIDINE GLUCONATE
ANDA #075561		 SUPPL-14 CHLORHEXIDINE GLUCONATE BAJAJ Manufacturing (CMC) Approval
11/17/2021 KEYTRUDA
BLA #125514		 SUPPL-113 PEMBROLIZUMAB MERCK SHARP DOHME Approval
11/17/2021 LEVETIRACETAM
ANDA #203468		 SUPPL-7 LEVETIRACETAM PRINSTON INC Manufacturing (CMC) Approval
11/17/2021 OXALIPLATIN
ANDA #204368		 SUPPL-3 OXALIPLATIN QILU PHARM HAINAN Labeling Approval
11/17/2021 OXALIPLATIN
ANDA #204368		 SUPPL-5 OXALIPLATIN QILU PHARM HAINAN Labeling Approval
11/17/2021 SIVEXTRO
NDA #205435		 SUPPL-14 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
11/17/2021 SIVEXTRO
NDA #205436		 SUPPL-9 TEDIZOLID PHOSPHATE CUBIST PHARMS LLC Labeling Approval
11/17/2021 DIFLUPREDNATE
ANDA #211526		 ORIG-1 DIFLUPREDNATE AMNEAL Approval
11/17/2021 SILDENAFIL CITRATE
ANDA #212312		 ORIG-1 SILDENAFIL CITRATE TRIS PHARMA INC Approval
11/17/2021 GALLIUM GA 68 GOZETOTIDE
NDA #212642		 SUPPL-1 GALLIUM GA-68 GOZETOTIDE UNIV CA LOS ANGELES Labeling Approval
11/17/2021 GALLIUM GA 68 GOZETOTIDE
NDA #212643		 SUPPL-1 GALLIUM GA-68 GOZETOTIDE UNIV OF CA SAN FRAN Labeling Approval
11/17/2021 SOAANZ
NDA #213218		 SUPPL-1 TORSEMIDE SARFE PHARMS Manufacturing (CMC) Approval
11/17/2021 NALOXONE HYDROCHLORIDE
ANDA #213279		 SUPPL-2 NALOXONE HYDROCHLORIDE EUGIA PHARMA Labeling Approval
11/17/2021 ELUXADOLINE
ANDA #213447		 ORIG-1 ELUXADOLINE SUN PHARM INDS LTD Tentative Approval
11/17/2021 NELARABINE
ANDA #215037		 ORIG-1 NELARABINE ZYDUS PHARMS Approval
11/17/2021 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #215047		 ORIG-1 ACETAMINOPHEN; BUTALBITAL; CAFFEINE NOVAST LABS Approval
11/17/2021 KETOCONAZOLE
ANDA #215185		 ORIG-1 KETOCONAZOLE TASMAN PHARMA Approval
11/18/2021 REMERON
NDA #020415		 SUPPL-38 MIRTAZAPINE ORGANON Labeling Approval
11/18/2021 REMERON SOLTAB
NDA #021208		 SUPPL-28 MIRTAZAPINE ORGANON USA ORGANON Labeling Approval
11/18/2021 AMPYRA
NDA #022250		 SUPPL-19 DALFAMPRIDINE ACORDA Labeling Approval
11/18/2021 OXALIPLATIN
ANDA #078811		 SUPPL-19 OXALIPLATIN FRESENIUS KABI USA Labeling Approval
11/18/2021 OXALIPLATIN
ANDA #078813		 SUPPL-10 OXALIPLATIN HOSPIRA WORLDWIDE Labeling Approval
11/18/2021 OXALIPLATIN
ANDA #078817		 SUPPL-25 OXALIPLATIN SANDOZ Labeling Approval
11/18/2021 RASAGILINE MESYLATE
ANDA #201942		 ORIG-1 RASAGILINE MESYLATE CARNEGIE Approval
11/18/2021 MESALAMINE
ANDA #203286		 SUPPL-3 MESALAMINE ZYDUS PHARMS Labeling Approval
11/18/2021 MESALAMINE
ANDA #203286		 SUPPL-4 MESALAMINE ZYDUS PHARMS Labeling Approval
11/18/2021 MESALAMINE
ANDA #203286		 SUPPL-7 MESALAMINE ZYDUS PHARMS Labeling Approval
11/18/2021 OLANZAPINE
ANDA #204319		 SUPPL-1 OLANZAPINE QILU Labeling Approval
11/18/2021 OLANZAPINE
ANDA #204319		 SUPPL-3 OLANZAPINE QILU Labeling Approval
11/18/2021 OLANZAPINE
ANDA #204319		 SUPPL-7 OLANZAPINE QILU Labeling Approval
11/18/2021 OLANZAPINE
ANDA #204319		 SUPPL-8 OLANZAPINE QILU Labeling Approval
11/18/2021 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #209192		 SUPPL-3 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Labeling Approval
11/18/2021 VANCOMYCIN HYDROCHLORIDE
ANDA #215821		 ORIG-1 VANCOMYCIN HYDROCHLORIDE HAINAN POLY Approval
11/19/2021 CALAN
NDA #018817		 SUPPL-35 VERAPAMIL HYDROCHLORIDE PFIZER Labeling Approval
11/19/2021 ADVIL COLD AND SINUS
NDA #019771		 SUPPL-45 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/19/2021 SUBUTEX
NDA #020732		 SUPPL-25 BUPRENORPHINE HYDROCHLORIDE INDIVIOR REMS Approval
11/19/2021 SUBOXONE
NDA #020733		 SUPPL-29 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
11/19/2021 ADVIL COLD AND SINUS
NDA #021374		 SUPPL-14 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/19/2021 CALDOLOR
NDA #022348		 SUPPL-21 IBUPROFEN CUMBERLAND PHARMS Efficacy Approval
11/19/2021 SUBOXONE
NDA #022410		 SUPPL-44 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
11/19/2021 ADVIL CONGESTION RELIEF
NDA #022565		 SUPPL-9 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/19/2021 KANUMA
BLA #125561		 SUPPL-13 SEBELIPASE ALFA ALEXION PHARM Approval
11/19/2021 OLANZAPINE
ANDA #202862		 SUPPL-10 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/19/2021 OLANZAPINE
ANDA #202862		 SUPPL-11 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/19/2021 OLANZAPINE
ANDA #202862		 SUPPL-18 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/19/2021 OLANZAPINE
ANDA #202862		 SUPPL-25 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/19/2021 OLANZAPINE
ANDA #202862		 SUPPL-26 OLANZAPINE MACLEODS PHARMS LTD Labeling Approval
11/19/2021 INJECTAFER
NDA #203565		 SUPPL-16 FERRIC CARBOXYMALTOSE AM REGENT Efficacy Approval
11/19/2021 NEBIVOLOL HYDROCHLORIDE
ANDA #203828		 SUPPL-3 NEBIVOLOL HYDROCHLORIDE INDCHEMIE HEALTH Labeling Approval
11/19/2021 ISOPROTERENOL HYDROCHLORIDE
ANDA #212189		 ORIG-1 ISOPROTERENOL HYDROCHLORIDE AVET LIFESCIENCES Approval
11/19/2021 DEFERASIROX
ANDA #214180		 ORIG-1 DEFERASIROX TEVA PHARMS USA Approval
11/19/2021 DECITABINE
ANDA #214486		 ORIG-1 DECITABINE ZYDUS PHARMS Approval
11/19/2021 VOXZOGO
NDA #214938		 ORIG-1 VOSORITIDE BIOMARIN PHARM Type 1 - New Molecular Entity Approval
11/22/2021 MERCAPTOPURINE
ANDA #040528		 SUPPL-12 MERCAPTOPURINE HIKMA Labeling Approval
11/22/2021 ZITHROMAX
NDA #050670		 SUPPL-36 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050693		 SUPPL-34 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050710		 SUPPL-51 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050711		 SUPPL-50 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050730		 SUPPL-43 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050733		 SUPPL-50 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZITHROMAX
NDA #050784		 SUPPL-37 AZITHROMYCIN PFIZER Labeling Approval
11/22/2021 ZMAX
NDA #050797		 SUPPL-26 AZITHROMYCIN PF PRISM CV Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065150		 SUPPL-20 AZITHROMYCIN TEVA Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065209		 SUPPL-32 AZITHROMYCIN SANDOZ Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065218		 SUPPL-24 AZITHROMYCIN PLIVA Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065302		 SUPPL-11 AZITHROMYCIN CHARTWELL RX Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065360		 SUPPL-10 AZITHROMYCIN AUROBINDO PHARMA USA Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065400		 SUPPL-19 AZITHROMYCIN LUPIN LTD Labeling Approval
11/22/2021 CIMETIDINE HYDROCHLORIDE
ANDA #074553		 SUPPL-8 CIMETIDINE HYDROCHLORIDE PHARM ASSOC Manufacturing (CMC) Approval
11/22/2021 AZITHROMYCIN
ANDA #207566		 SUPPL-2 AZITHROMYCIN CSPC OUYI Labeling Approval
11/22/2021 DOXYCYCLINE HYCLATE
ANDA #208263		 ORIG-1 DOXYCYCLINE HYCLATE NESHER PHARMS Approval
11/22/2021 ABIRATERONE ACETATE
ANDA #208453		 SUPPL-1 ABIRATERONE ACETATE APOTEX Labeling Approval
11/22/2021 ABIRATERONE ACETATE
ANDA #208453		 SUPPL-9 ABIRATERONE ACETATE APOTEX Labeling Approval
11/22/2021 ABIRATERONE ACETATE
ANDA #208453		 SUPPL-11 ABIRATERONE ACETATE APOTEX Labeling Approval
11/22/2021 ABIRATERONE ACETATE
ANDA #208453		 SUPPL-12 ABIRATERONE ACETATE APOTEX Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #209043		 SUPPL-8 AZITHROMYCIN SUNSHINE Labeling Approval
11/22/2021 SILODOSIN
ANDA #209745		 SUPPL-3 SILODOSIN AMNEAL PHARMS CO Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #209999		 SUPPL-2 AZITHROMYCIN BIONPHARMA Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #211068		 SUPPL-2 AZITHROMYCIN YUNG SHIN PHARM Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #211793		 SUPPL-5 AZITHROMYCIN ALEMBIC Labeling Approval
11/22/2021 FYARRO
NDA #213312		 ORIG-1 SIROLIMUS AADI Type 5 - New Formulation or New Manufacturer Approval
11/22/2021 CANGRELOR
ANDA #213703		 ORIG-1 CANGRELOR MSN PHARMACEUTICALS INC Tentative Approval
11/22/2021 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #214347		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ACCORD HLTHCARE Approval
11/22/2021 NIACIN
ANDA #214428		 ORIG-1 NIACIN BEIJING Approval
11/22/2021 FORMOTEROL FUMARATE
ANDA #215078		 ORIG-1 FORMOTEROL FUMARATE ALEMBIC Approval
11/22/2021 DIGOXIN
ANDA #215307		 ORIG-1 DIGOXIN NOVITIUM PHARMA Approval
11/22/2021 LYVISPAH
NDA #215422		 ORIG-1 BACLOFEN AMNEAL Type 3 - New Dosage Form Approval
11/22/2021 ULTOMIRIS
BLA #761108		 SUPPL-24 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
11/23/2021 ADVIL ALLERGY SINUS
NDA #021441		 SUPPL-16 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/23/2021 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113		 SUPPL-11 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/23/2021 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113		 SUPPL-11 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE HALEON US HOLDINGS Labeling Approval
11/23/2021 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #078992		 ORIG-2 DEXMETHYLPHENIDATE HYDROCHLORIDE INTELLIPHARMACEUTICS Approval
11/23/2021 DASATINIB
ANDA #203180		 ORIG-1 DASATINIB APOTEX Approval
11/23/2021 EVEROLIMUS
ANDA #207486		 ORIG-2 EVEROLIMUS HIKMA Approval
11/23/2021 TPOXX
NDA #208627		 SUPPL-6 TECOVIRIMAT SIGA TECHNOLOGIES Efficacy Approval
11/23/2021 ISOSORBIDE DINITRATE
ANDA #211290		 ORIG-1 ISOSORBIDE DINITRATE PAR PHARM INC Approval
11/23/2021 INREBIC
NDA #212327		 SUPPL-4 FEDRATINIB HYDROCHLORIDE BRISTOL-MYERS Labeling Approval
11/23/2021 TEMOZOLOMIDE
ANDA #213328		 ORIG-1 TEMOZOLOMIDE NIVAGEN PHARMS INC Approval
11/23/2021 BETAINE
ANDA #214864		 ORIG-1 BETAINE NOVITIUM PHARMA Approval
11/23/2021 LIVTENCITY
NDA #215596		 ORIG-1 MARIBAVIR TAKEDA PHARMS USA Type 1 - New Molecular Entity Approval
11/24/2021 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-19 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
11/24/2021 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077528		 SUPPL-20 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
11/24/2021 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-24 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
11/24/2021 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #202074		 SUPPL-18 FLUOXETINE HYDROCHLORIDE; OLANZAPINE TEVA PHARMS Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-2 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-3 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-5 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-6 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-7 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-8 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202285		 SUPPL-10 OLANZAPINE MYLAN Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202287		 SUPPL-2 OLANZAPINE ORBION PHARMS Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202287		 SUPPL-3 OLANZAPINE ORBION PHARMS Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202287		 SUPPL-4 OLANZAPINE ORBION PHARMS Labeling Approval
11/24/2021 OLANZAPINE
ANDA #202287		 SUPPL-5 OLANZAPINE ORBION PHARMS Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #202366		 SUPPL-3 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #202366		 SUPPL-4 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #202366		 SUPPL-5 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #202366		 SUPPL-7 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #202366		 SUPPL-8 LANSOPRAZOLE ZYDUS HLTHCARE Labeling Approval
11/24/2021 LANSOPRAZOLE
ANDA #203187		 SUPPL-3 LANSOPRAZOLE MYLAN Labeling Approval
11/24/2021 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205022		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE LANNETT CO INC Labeling Approval
11/26/2021 INTRON A
BLA #103132		 SUPPL-5202 INTERFERON ALFA-2B SCHERING Approval
11/26/2021 EVEROLIMUS
ANDA #214138		 ORIG-1 EVEROLIMUS ALKEM LABS LTD Approval
11/26/2021 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #214403		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE LANNETT CO INC Approval
11/26/2021 DAPTOMYCIN
ANDA #215215		 ORIG-1 DAPTOMYCIN HANGZHOU ZHONGMEI Approval
11/26/2021 ATROPINE SULFATE
ANDA #215624		 ORIG-1 ATROPINE SULFATE APOTEX Approval
11/29/2021 AZTREONAM
ANDA #065439		 SUPPL-9 AZTREONAM FRESENIUS KABI USA Labeling Approval
11/29/2021 AZTREONAM
ANDA #065439		 SUPPL-14 AZTREONAM FRESENIUS KABI USA Labeling Approval
11/29/2021 RIBAVIRIN
ANDA #076277		 SUPPL-13 RIBAVIRIN TEVA Labeling Approval
11/29/2021 URSODIOL
ANDA #090801		 SUPPL-5 URSODIOL GLENMARK PHARMS LTD Labeling Approval
11/29/2021 FENOFIBRIC ACID
ANDA #200264		 SUPPL-4 CHOLINE FENOFIBRATE IMPAX LABS INC Labeling Approval
11/29/2021 FENOFIBRIC ACID
ANDA #200750		 SUPPL-16 CHOLINE FENOFIBRATE CHARTWELL RX Labeling Approval
11/29/2021 OLANZAPINE
ANDA #202937		 SUPPL-1 OLANZAPINE ORBION PHARMS Labeling Approval
11/29/2021 OLANZAPINE
ANDA #202937		 SUPPL-2 OLANZAPINE ORBION PHARMS Labeling Approval
11/29/2021 OLANZAPINE
ANDA #202937		 SUPPL-3 OLANZAPINE ORBION PHARMS Labeling Approval
11/29/2021 OLANZAPINE
ANDA #202937		 SUPPL-4 OLANZAPINE ORBION PHARMS Labeling Approval
11/29/2021 LUMIFY
NDA #208144		 SUPPL-13 BRIMONIDINE TARTRATE BAUSCH AND LOMB INC Labeling Approval
11/29/2021 MIGLUSTAT
ANDA #208342		 SUPPL-3 MIGLUSTAT ANI PHARMS Labeling Approval
11/29/2021 CHLORPROMAZINE HYDROCHLORIDE
ANDA #212630		 ORIG-1 CHLORPROMAZINE HYDROCHLORIDE ZAMEER PHARMS Approval
11/29/2021 MYCOPHENOLIC SODIUM
ANDA #214630		 ORIG-1 MYCOPHENOLIC SODIUM BIOCON PHARMA Approval
11/29/2021 CYTALUX
NDA #214907		 ORIG-1 PAFOLACIANINE SODIUM ON TARGET LABS Type 1 - New Molecular Entity Approval
11/30/2021 DEPAKOTE
NDA #018723		 SUPPL-65 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/30/2021 DEPAKOTE
NDA #019680		 SUPPL-52 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/30/2021 ESTROGEL
NDA #021166		 SUPPL-17 ESTRADIOL ASCEND THERAPS US Labeling Approval
11/30/2021 DEPAKOTE ER
NDA #021168		 SUPPL-43 DIVALPROEX SODIUM ABBVIE Labeling Approval
11/30/2021 FERRIPROX
NDA #021825		 SUPPL-10 DEFERIPRONE CHIESI Labeling Approval
11/30/2021 STAVZOR
NDA #022152		 SUPPL-9 VALPROIC ACID BIONPHARMA Labeling Approval
11/30/2021 MESALAMINE
ANDA #202065		 SUPPL-1 MESALAMINE SANDOZ Labeling Approval
11/30/2021 KYPROLIS
NDA #202714		 SUPPL-33 CARFILZOMIB ONYX PHARMS AMGEN Efficacy Approval
11/30/2021 POLYETHYLENE GLYCOL 3350
ANDA #202850		 SUPPL-2 POLYETHYLENE GLYCOL 3350 ANI PHARMS Labeling Approval
11/30/2021 FERRIPROX
NDA #208030		 SUPPL-7 DEFERIPRONE CHIESI Labeling Approval
11/30/2021 LUBIPROSTONE
ANDA #209450		 ORIG-1 LUBIPROSTONE AMNEAL Approval
11/30/2021 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-10 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
11/30/2021 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-17 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
11/30/2021 ATORVASTATIN CALCIUM
ANDA #209912		 SUPPL-18 ATORVASTATIN CALCIUM GRAVITI PHARMS Labeling Approval
11/30/2021 BACLOFEN
ANDA #211555		 SUPPL-6 BACLOFEN EYWA PHARMA Manufacturing (CMC) Approval
11/30/2021 FERRIPROX
NDA #212269		 SUPPL-3 DEFERIPRONE CHIESI Labeling Approval
11/30/2021 SUNITINIB MALATE
ANDA #213803		 ORIG-1 SUNITINIB MALATE TEVA PHARMS USA Approval
11/30/2021 DARZALEX FASPRO
BLA #761145		 SUPPL-9 DARATUMUMAB;HYALURONIDASE-FIHJ JANSSEN BIOTECH Approval
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