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 December 09, 2021.

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 ALLERGAN 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 APIL 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 VALEANT PHARMS INTL 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 APIL 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 LTD Labeling Approval
11/01/2021 QUETIAPINE FUMARATE
ANDA #207655
SUPPL-6 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
11/01/2021 QUETIAPINE FUMARATE
ANDA #207655
SUPPL-7 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
11/01/2021 ACYCLOVIR
ANDA #208766
SUPPL-2 ACYCLOVIR AMNEAL Labeling Approval
11/01/2021 DROXIDOPA
ANDA #215265
ORIG-1 DROXIDOPA SLATE Approval
11/02/2021 VYVANSE
NDA #021977
SUPPL-47 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
11/02/2021 PANCREAZE
BLA #022523
SUPPL-16 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) VIVUS INC 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 BREXPIPRAZOLE
ANDA #213562
ORIG-1 BREXPIPRAZOLE AMNEAL EU LTD Tentative Approval
11/02/2021 LEVOLEUCOVORIN CALCIUM
ANDA #213797
ORIG-1 LEVOLEUCOVORIN CALCIUM PRAXGEN 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)
NDA #020802
SUPPL-38 ACETAMINOPHEN; ASPIRIN; CAFFEINE GLAXOSMITHKLINE CONS 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 GLAXOSMITHKLINE CONS 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 EXTAVIA
BLA #125290
SUPPL-73 INTERFERON BETA-1B NOVARTIS PHARMS 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 HONG KONG Approval
11/03/2021 GATIFLOXACIN
ANDA #213542
ORIG-1 GATIFLOXACIN TORRENT Approval
11/03/2021 MYCOPHENOLIC ACID
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 MERCK SHARP DOHME Labeling Approval
11/04/2021 JANUMET XR
NDA #202270
SUPPL-25 METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE MERCK SHARP DOHME Labeling Approval
11/04/2021 DYANAVEL XR
NDA #210526
ORIG-1 AMPHETAMINE 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 DOUGLAS PHARMS 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 INC Approval
11/08/2021 TRANEXAMIC ACID
ANDA #206594
SUPPL-4 TRANEXAMIC ACID AKORN 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 INC Labeling Approval
11/08/2021 MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #209642
ORIG-1 MAGNESIUM SULFATE PTS CONSULTING 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
ANDA #215082
ORIG-1 LINCOMYCIN 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 GLAXOSMITHKLINE CONS 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 MAYNE PHARMA 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 AKORN 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
11/09/2021 ESTRADIOL; PROGESTERONE
ANDA #214293
ORIG-1 ESTRADIOL;PROGESTERONE AMNEAL PHARMS NY Tentative 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 MAYNE PHARMA REMS Approval
11/10/2021 CLOZAPINE
ANDA #206433
SUPPL-13 CLOZAPINE AUROBINDO PHARMA LTD 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 GENENTECH INC 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 INC 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 STRIDES PHARMA 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 OBETICHOLIC ACID
ANDA #214899
ORIG-1 OBETICHOLIC ACID DR REDDYS LABS LTD Tentative 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 MYLAN 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 AKORN 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 THERAPEUTICSMD INC 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 ALEOR DERMACEUTICALS 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 PHARM INDS LTD Approval
11/16/2021 PREDNISONE
ANDA #215671
ORIG-1 PREDNISONE AUROBINDO PHARMA LTD Approval
11/17/2021 TIMOPTIC
NDA #018086
SUPPL-80 TIMOLOL MALEATE VALEANT PHARMS INTL 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 AKORN 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 PSMA-11
NDA #212642
SUPPL-1 GALLIUM GA-68 PSMA-11 UNIV CA LOS ANGELES Labeling Approval
11/17/2021 GALLIUM GA 68 PSMA-11
NDA #212643
SUPPL-1 GALLIUM GA-68 PSMA-11 UNIV OF CA SAN FRAN Labeling 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 RICONPHARMA LLC Approval
11/17/2021 KETOCONAZOLE
ANDA #215185
ORIG-1 KETOCONAZOLE TASMAN PHARMA Approval
11/18/2021 REMERON
NDA #020415
SUPPL-38 MIRTAZAPINE ORGANON USA INC Labeling Approval
11/18/2021 REMERON SOLTAB
NDA #021208
SUPPL-28 MIRTAZAPINE ORGANON USA INC 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 DR REDDYS 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 GLAXOSMITHKLINE Labeling Approval
11/19/2021 SUBUTEX
NDA #020732
SUPPL-25 BUPRENORPHINE HYDROCHLORIDE INDIVIOR INC REMS Approval
11/19/2021 SUBOXONE
NDA #020733
SUPPL-29 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR INC REMS Approval
11/19/2021 ADVIL COLD AND SINUS
NDA #021374
SUPPL-14 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE GLAXOSMITHKLINE 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 INC REMS Approval
11/19/2021 ADVIL CONGESTION RELIEF
NDA #022565
SUPPL-9 IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE GLAXOSMITHKLINE 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 WOCKHARDT Labeling Approval
11/22/2021 AZITHROMYCIN
ANDA #065360
SUPPL-10 AZITHROMYCIN MYLAN 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 DABIGATRAN ETEXILATE MESYLATE
ANDA #208046
ORIG-1 DABIGATRAN ETEXILATE MESYLATE ALEMBIC PHARMS LTD Tentative 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 INC 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 PHARMS LTD Labeling Approval
11/22/2021 FYARRO
NDA #213312
ORIG-1 SIROLIMUS ALBUMIN-BOUND NANOPARTICLES AADI BIOSCIENCE INC Type 5 - New Formulation or New Manufacturer 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 PHARMS LTD Approval
11/22/2021 DIGOXIN
ANDA #215307
ORIG-1 DIGOXIN NOVITIUM PHARMA Approval
11/22/2021 LYVISPAH
NDA #215422
ORIG-1 BACLOFEN SAOL THERAPS RES LTD 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 GLAXOSMITHKLINE Labeling Approval
11/23/2021 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113
SUPPL-11 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
11/23/2021 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113
SUPPL-11 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE GLAXOSMITHKLINE 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 IMPACT 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 DETROAMP 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 INC 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 GENERICS 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 LUPIN LTD 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 ENALTEC Approval
11/29/2021 MYCOPHENOLIC ACID
ANDA #214630
ORIG-1 MYCOPHENOLIC ACID BIOCON PHARMA Approval
11/29/2021 CYTALUX
NDA #214907
ORIG-1 PAFOLACIANINE ON TARGET LABROTORIES, INC. 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 INC Labeling Approval
11/30/2021 MESALAMINE
ANDA #202065
SUPPL-1 MESALAMINE SANDOZ INC Labeling Approval
11/30/2021 KYPROLIS
NDA #202714
SUPPL-33 CARFILZOMIB ONYX THERAP 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 REGADENOSON
ANDA #213210
ORIG-1 REGADENOSON DR REDDYS LABS LTD Tentative 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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