U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
May 2023

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 18, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/2023 TACROLIMUS
ANDA #065461		 SUPPL-35 TACROLIMUS SANDOZ Labeling Approval
05/01/2023 TACROLIMUS
ANDA #065461		 SUPPL-36 TACROLIMUS SANDOZ Labeling Approval
05/01/2023 TACROLIMUS
ANDA #065461		 SUPPL-37 TACROLIMUS SANDOZ Labeling Approval
05/01/2023 OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #077742		 SUPPL-19 FLUOXETINE HYDROCHLORIDE; OLANZAPINE PAR PHARM Labeling Approval
05/01/2023 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078244		 SUPPL-6 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
05/01/2023 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078244		 SUPPL-8 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
05/01/2023 ONDANSETRON HYDROCHLORIDE
ANDA #078257		 SUPPL-6 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
05/01/2023 ONDANSETRON HYDROCHLORIDE
ANDA #078257		 SUPPL-8 ONDANSETRON HYDROCHLORIDE STERISCIENCE Labeling Approval
05/01/2023 DESLORATADINE
ANDA #078355		 SUPPL-4 DESLORATADINE BELCHER PHARMS Labeling Approval
05/01/2023 CLONAZEPAM
ANDA #078654		 SUPPL-11 CLONAZEPAM SUN PHARM INDS INC Manufacturing (CMC) Approval
05/01/2023 TELMISARTAN
ANDA #078710		 SUPPL-7 TELMISARTAN CHARTWELL RX Manufacturing (CMC) Approval
05/01/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #088262		 SUPPL-36 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
05/01/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #088276		 SUPPL-36 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
05/01/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #088292		 SUPPL-36 IMIPRAMINE HYDROCHLORIDE STRIDES PHARMA Labeling Approval
05/01/2023 MESALAMINE
ANDA #091640		 SUPPL-20 MESALAMINE ZYDUS PHARMS Labeling Approval
05/01/2023 CABERGOLINE
ANDA #202947		 SUPPL-2 CABERGOLINE MYLAN Labeling Approval
05/01/2023 DICLOFENAC POTASSIUM
ANDA #202964		 SUPPL-3 DICLOFENAC POTASSIUM PAR FORM Labeling Approval
05/01/2023 NIFEDIPINE
ANDA #202987		 SUPPL-3 NIFEDIPINE NOVAST LABS Labeling Approval
05/01/2023 LAPATINIB DITOSYLATE
ANDA #203007		 SUPPL-3 LAPATINIB DITOSYLATE NATCO PHARMA LTD Labeling Approval
05/01/2023 FOSAPREPITANT DIMEGLUMINE
ANDA #203939		 SUPPL-2 FOSAPREPITANT DIMEGLUMINE SANDOZ Labeling Approval
05/01/2023 FOSAPREPITANT DIMEGLUMINE
ANDA #203939		 SUPPL-3 FOSAPREPITANT DIMEGLUMINE SANDOZ Labeling Approval
05/01/2023 DALFAMPRIDINE
ANDA #206646		 SUPPL-3 DALFAMPRIDINE HIKMA Labeling Approval
05/01/2023 DALFAMPRIDINE
ANDA #206646		 SUPPL-4 DALFAMPRIDINE HIKMA Labeling Approval
05/01/2023 DALFAMPRIDINE
ANDA #206765		 SUPPL-11 DALFAMPRIDINE ALKEM LABS LTD Labeling Approval
05/01/2023 DALFAMPRIDINE
ANDA #206811		 SUPPL-9 DALFAMPRIDINE AUROBINDO PHARMA Labeling Approval
05/01/2023 DALFAMPRIDINE
ANDA #206863		 SUPPL-3 DALFAMPRIDINE ACCORD HLTHCARE Labeling Approval
05/01/2023 CLOBAZAM
ANDA #208819		 SUPPL-6 CLOBAZAM BIONPHARMA Labeling Approval
05/01/2023 CLOBAZAM
ANDA #209308		 SUPPL-9 CLOBAZAM BRECKENRIDGE Labeling Approval
05/01/2023 CLOBAZAM
ANDA #209715		 SUPPL-2 CLOBAZAM HIKMA Labeling Approval
05/01/2023 CLOBAZAM
ANDA #209795		 SUPPL-4 CLOBAZAM HETERO LABS LTD III Labeling Approval
05/01/2023 BIKTARVY
NDA #210251		 SUPPL-17 BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
05/01/2023 CLOBAZAM
ANDA #210545		 SUPPL-4 CLOBAZAM LUPIN LTD Labeling Approval
05/01/2023 CLOBAZAM
ANDA #210546		 SUPPL-4 CLOBAZAM LUPIN LTD Labeling Approval
05/01/2023 CLOBAZAM
ANDA #211259		 SUPPL-4 CLOBAZAM MYLAN Labeling Approval
05/01/2023 CLOBAZAM
ANDA #211711		 SUPPL-4 CLOBAZAM MICRO LABS Labeling Approval
05/01/2023 CLOBAZAM
ANDA #211959		 SUPPL-3 CLOBAZAM CELLTRION Labeling Approval
05/01/2023 CLOBAZAM
ANDA #212714		 SUPPL-2 CLOBAZAM ALKEM LABS LTD Labeling Approval
05/01/2023 CLOBAZAM
ANDA #212714		 SUPPL-4 CLOBAZAM ALKEM LABS LTD Labeling Approval
05/01/2023 LUMRYZ
NDA #214755		 ORIG-1 SODIUM OXYBATE AVADEL CNS Approval
05/01/2023 AMITRIPTYLINE HYDROCHLORIDE
ANDA #215376		 ORIG-1 AMITRIPTYLINE HYDROCHLORIDE RUBICON Approval
05/01/2023 LETROZOLE;VRIBOCICLIB SUCCINATE
ANDA #215975		 ORIG-1 LETROZOLE;RIBOCICLIB SUCCINATE MSN LABS PVT LTD Tentative Approval
05/01/2023 TIROFIBAN HYDROCHLORIDE
ANDA #216379		 ORIG-1 TIROFIBAN HYDROCHLORIDE EUGIA PHARMA Approval
05/01/2023 METHSUXIMIDE
ANDA #217213		 ORIG-1 METHSUXIMIDE NOVITIUM PHARMA Approval
05/01/2023 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #217260		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE INGENUS PHARMS LLC Approval
05/02/2023 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-23 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 ALPRAZOLAM
ANDA #074174		 SUPPL-15 ALPRAZOLAM NOVITIUM PHARMA Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-4 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-5 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-10 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-11 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-12 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-16 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-19 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-21 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090745		 SUPPL-26 DULOXETINE HYDROCHLORIDE SUN PHARM Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-8 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-10 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-11 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-14 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-17 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #090776		 SUPPL-18 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-11 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-13 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-14 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #202045		 SUPPL-16 DULOXETINE HYDROCHLORIDE APOTEX Labeling Approval
05/02/2023 ESZOPICLONE
ANDA #202929		 SUPPL-27 ESZOPICLONE MACLEODS PHARMS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #203197		 SUPPL-3 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #203197		 SUPPL-4 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #203197		 SUPPL-7 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #203197		 SUPPL-11 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #203197		 SUPPL-15 DULOXETINE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #206653		 SUPPL-7 DULOXETINE HYDROCHLORIDE PRINSTON INC Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #206653		 SUPPL-8 DULOXETINE HYDROCHLORIDE PRINSTON INC Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #206653		 SUPPL-9 DULOXETINE HYDROCHLORIDE PRINSTON INC Labeling Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #206653		 SUPPL-10 DULOXETINE HYDROCHLORIDE PRINSTON INC Labeling Approval
05/02/2023 PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-8 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-8 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
05/02/2023 LUMIFY
NDA #208144		 SUPPL-15 BRIMONIDINE TARTRATE BAUSCH AND LOMB INC Manufacturing (CMC) Approval
05/02/2023 CLOMIPRAMINE HYDROCHLORIDE
ANDA #208632		 SUPPL-6 CLOMIPRAMINE HYDROCHLORIDE AMNEAL PHARMS CO Labeling Approval
05/02/2023 MOXIFLOXACIN HYDROCHLORIDE
ANDA #208778		 SUPPL-1 MOXIFLOXACIN HYDROCHLORIDE GLAND PHARMA LTD Labeling Approval
05/02/2023 ERTAPENEM SODIUM
ANDA #209145		 ORIG-1 ERTAPENEM SODIUM SUN PHARM Approval
05/02/2023 DULOXETINE HYDROCHLORIDE
ANDA #210599		 SUPPL-1 DULOXETINE HYDROCHLORIDE QINGDAO BAHEAL PHARM Labeling Approval
05/02/2023 LEVOTHYROXINE SODIUM
ANDA #211369		 SUPPL-5 LEVOTHYROXINE SODIUM TEVA PHARMS USA INC Manufacturing (CMC) Approval
05/02/2023 ELIGLUSTAT TARTRATE
ANDA #212420		 ORIG-1 ELIGLUSTAT TARTRATE UPSHER SMITH LABS Approval
05/03/2023 TOPAMAX
NDA #020505		 SUPPL-65 TOPIRAMATE JANSSEN PHARMS Labeling Approval
05/03/2023 TOPAMAX
NDA #020844		 SUPPL-56 TOPIRAMATE JANSSEN PHARMS Labeling Approval
05/03/2023 TOPAMAX SPRINKLE
NDA #020844		 SUPPL-56 TOPIRAMATE JANSSEN PHARMS Labeling Approval
05/03/2023 KALYDECO
NDA #203188		 SUPPL-38 IVACAFTOR VERTEX PHARMS Labeling Approval
05/03/2023 KALYDECO
NDA #207925		 SUPPL-16 IVACAFTOR VERTEX PHARMS INC Efficacy Approval
05/03/2023 CLOBAZAM
ANDA #209808		 SUPPL-2 CLOBAZAM PIRAMAL HLTHCARE UK Labeling Approval
05/03/2023 ACETAMINOPHEN
ANDA #215403		 ORIG-1 ACETAMINOPHEN INFORLIFE Approval
05/03/2023 SUCRALFATE
ANDA #215705		 ORIG-1 SUCRALFATE ZYDUS LIFESCIENCES Approval
05/03/2023 SAFINAMIDE
ANDA #215945		 ORIG-1 SAFINAMIDE RK PHARMA Tentative Approval
05/03/2023 EDETATE CALCIUM DISODIUM
ANDA #216435		 ORIG-1 EDETATE CALCIUM DISODIUM CASPER PHARMA LLC Approval
05/03/2023 NICARDIPINE HYDROCHLORIDE
ANDA #217555		 ORIG-1 NICARDIPINE HYDROCHLORIDE BIONPHARMA Approval
05/04/2023 SKYLA
NDA #203159		 SUPPL-14 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
05/04/2023 TOPIRAMATE
ANDA #205976		 ORIG-2 TOPIRAMATE PAR PHARM Approval
05/04/2023 KYLEENA
NDA #208224		 SUPPL-5 LEVONORGESTREL BAYER HLTHCARE Labeling Approval
05/04/2023 CINACALCET HYDROCHLORIDE
ANDA #208368		 SUPPL-3 CINACALCET HYDROCHLORIDE DR REDDYS Labeling Approval
05/04/2023 SODIUM PHENYLACETATE AND SODIUM BENZOATE
ANDA #208521		 SUPPL-2 SODIUM BENZOATE; SODIUM PHENYLACETATE MAIA PHARMS INC Labeling Approval
05/04/2023 ITRACONAZOLE
ANDA #208591		 SUPPL-9 ITRACONAZOLE ALKEM LABS LTD Labeling Approval
05/04/2023 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #211563		 ORIG-1 DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE ALKEM LABS LTD Tentative Approval
05/04/2023 LENALIDOMIDE
ANDA #215759		 ORIG-1 LENALIDOMIDE BIOCON PHARMA LTD Tentative Approval
05/04/2023 MOTPOLY XR
NDA #216185		 ORIG-1 LACOSAMIDE AUCTA Type 3 - New Dosage Form Approval
05/05/2023 IBUPROFEN
ANDA #079205		 SUPPL-5 IBUPROFEN MARKSANS PHARMA Labeling Approval
05/05/2023 IBUPROFEN
ANDA #079205		 SUPPL-11 IBUPROFEN MARKSANS PHARMA Labeling Approval
05/05/2023 HYDROXYCHLOROQUINE SULFATE
ANDA #201691		 SUPPL-7 HYDROXYCHLOROQUINE SULFATE ALKALOIDA ZRT Labeling Approval
05/05/2023 LAMIVUDINE
ANDA #202941		 SUPPL-5 LAMIVUDINE APOTEX Labeling Approval
05/05/2023 POTASSIUM CHLORIDE
ANDA #203002		 SUPPL-4 POTASSIUM CHLORIDE LUPIN LTD Labeling Approval
05/05/2023 METOPROLOL SUCCINATE
ANDA #203894		 SUPPL-8 METOPROLOL SUCCINATE ZYDUS PHARMS Labeling Approval
05/05/2023 METOPROLOL SUCCINATE
ANDA #203894		 SUPPL-10 METOPROLOL SUCCINATE ZYDUS PHARMS Labeling Approval
05/05/2023 SIMBRINZA
NDA #204251		 SUPPL-12 BRIMONIDINE TARTRATE; BRINZOLAMIDE ALCON LABS INC Labeling Approval
05/05/2023 CARIPRAZINE
ANDA #213982		 ORIG-1 CARIPRAZINE AUROBINDO PHARMA LTD Tentative Approval
05/05/2023 MYDCOMBI
NDA #215352		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE EYENOVIA Type 5 - New Formulation or New Manufacturer Approval
05/05/2023 METHYLNALTREXONE BROMIDE
ANDA #216836		 ORIG-1 METHYLNALTREXONE BROMIDE GLAND PHARMA LTD Tentative Approval
05/08/2023 ZYRTEC ALLERGY
NDA #019835		 SUPPL-45 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
05/08/2023 ZYRTEC HIVES RELIEF
NDA #019835		 SUPPL-45 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
05/08/2023 RIBAVIRIN
ANDA #077053		 SUPPL-14 RIBAVIRIN HERITAGE PHARMA AVET Labeling Approval
05/08/2023 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-18 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
05/08/2023 RABEPRAZOLE SODIUM
ANDA #078964		 SUPPL-20 RABEPRAZOLE SODIUM CHARTWELL RX Labeling Approval
05/08/2023 LITHIUM CARBONATE
ANDA #079139		 SUPPL-12 LITHIUM CARBONATE GLENMARK PHARMS LTD Labeling Approval
05/08/2023 DILANTIN
ANDA #084427		 SUPPL-45 PHENYTOIN PHARMACIA Labeling Approval
05/08/2023 GLATOPA
ANDA #090218		 SUPPL-27 GLATIRAMER ACETATE SANDOZ Labeling Approval
05/08/2023 VALACYCLOVIR HYDROCHLORIDE
ANDA #090682		 SUPPL-17 VALACYCLOVIR HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
05/08/2023 VALACYCLOVIR HYDROCHLORIDE
ANDA #090682		 SUPPL-20 VALACYCLOVIR HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
05/08/2023 CLOPIDOGREL BISULFATE
ANDA #091023		 SUPPL-20 CLOPIDOGREL BISULFATE DR REDDYS LABS LTD Labeling Approval
05/08/2023 LINEZOLID
ANDA #200068		 SUPPL-7 LINEZOLID HIKMA Labeling Approval
05/08/2023 LINEZOLID
ANDA #200068		 SUPPL-8 LINEZOLID HIKMA Labeling Approval
05/08/2023 FARXIGA
NDA #202293		 SUPPL-26 DAPAGLIFLOZIN ASTRAZENECA AB Efficacy Approval
05/08/2023 ATOMOXETINE HYDROCHLORIDE
ANDA #202682		 SUPPL-1 ATOMOXETINE HYDROCHLORIDE HETERO LABS LTD V Labeling Approval
05/08/2023 BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #202940		 SUPPL-4 BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE PHARM ASSOC Labeling Approval
05/08/2023 MYCOPHENOLATE MOFETIL
ANDA #203005		 SUPPL-18 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
05/08/2023 DILTIAZEM HYDROCHLORIDE
ANDA #203023		 SUPPL-10 DILTIAZEM HYDROCHLORIDE SUN PHARM Labeling Approval
05/08/2023 MORPHINE SULFATE
ANDA #206573		 SUPPL-2 MORPHINE SULFATE PHARM ASSOC Labeling Approval
05/08/2023 MORPHINE SULFATE
ANDA #206573		 SUPPL-4 MORPHINE SULFATE PHARM ASSOC Labeling Approval
05/08/2023 MORPHINE SULFATE
ANDA #206573		 SUPPL-6 MORPHINE SULFATE PHARM ASSOC Labeling Approval
05/08/2023 MORPHINE SULFATE
ANDA #206573		 SUPPL-8 MORPHINE SULFATE PHARM ASSOC Labeling Approval
05/08/2023 MORPHINE SULFATE
ANDA #206573		 SUPPL-10 MORPHINE SULFATE PHARM ASSOC Labeling Approval
05/08/2023 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206931		 SUPPL-6 DEXMETHYLPHENIDATE HYDROCHLORIDE ABHAI INC Labeling Approval
05/08/2023 METOPROLOL SUCCINATE
ANDA #210597		 SUPPL-1 METOPROLOL SUCCINATE PRINSTON INC Labeling Approval
05/08/2023 CEFAZOLIN SODIUM
NDA #211413		 ORIG-1 CEFAZOLIN SODIUM HQ SPCLT PHARMA Type 5 - New Formulation or New Manufacturer Approval
05/08/2023 ROCURONIUM BROMIDE
ANDA #213453		 ORIG-1 ROCURONIUM BROMIDE MEITHEAL Approval
05/08/2023 ALBUTEROL SULFATE
ANDA #214531		 SUPPL-1 ALBUTEROL SULFATE RITEDOSE CORP Labeling Approval
05/08/2023 IVERMECTIN
ANDA #215210		 SUPPL-1 IVERMECTIN ZYDUS LIFESCIENCES Labeling Approval
05/08/2023 BYLVAY
NDA #215498		 SUPPL-4 ODEVIXIBAT IPSEN Labeling Approval
05/08/2023 PHENOXYBENZAMINE HYDROCHLORIDE
ANDA #215600		 ORIG-1 PHENOXYBENZAMINE HYDROCHLORIDE AUROBINDO PHARMA Approval
05/08/2023 PHENOXYBENZAMINE HYDROCHLORIDE
ANDA #215600		 SUPPL-1 PHENOXYBENZAMINE HYDROCHLORIDE AUROBINDO PHARMA Approval
05/08/2023 TIMOLOL MALEATE
ANDA #217195		 ORIG-1 TIMOLOL MALEATE SENTISS PHARMA Approval
05/09/2023 ELELYSO
BLA #022458		 SUPPL-30 TALIGLUCERASE ALFA PFIZER Approval
05/09/2023 QSYMIA
NDA #022580		 SUPPL-22 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE VIVUS REMS Approval
05/09/2023 CLINDAMYCIN HYDROCHLORIDE
ANDA #065442		 SUPPL-19 CLINDAMYCIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
05/09/2023 METOPROLOL SUCCINATE
ANDA #090617		 SUPPL-14 METOPROLOL SUCCINATE DR REDDYS LABS LTD Labeling Approval
05/09/2023 METOPROLOL SUCCINATE
ANDA #090617		 SUPPL-17 METOPROLOL SUCCINATE DR REDDYS LABS LTD Labeling Approval
05/09/2023 MYCOPHENOLIC SODIUM
ANDA #208315		 SUPPL-2 MYCOPHENOLIC SODIUM ALKEM LABS LTD Labeling Approval
05/09/2023 ANGIOMAX RTU
NDA #211215		 SUPPL-2 BIVALIRUDIN MAIA PHARMS INC Labeling Approval
05/09/2023 ZOLPIDEM TARTRATE
NDA #215721		 ORIG-1 ZOLPIDEM TARTRATE ALMATICA Type 3 - New Dosage Form Approval
05/09/2023 RIBOCICLIB
ANDA #215976		 ORIG-1 RIBOCICLIB MSN LABS PVT LTD Tentative Approval
05/09/2023 ACETAZOLAMIDE
ANDA #217197		 ORIG-1 ACETAZOLAMIDE NE RX PHARMA Approval
05/09/2023 DEXAMETHASONE
ANDA #217696		 ORIG-1 DEXAMETHASONE NOVITIUM PHARMA Approval
05/09/2023 ELFABRIO
BLA #761161		 ORIG-1 PEGUNIGALSIDASE ALFA-IWXJ CHIESI FARMACEUTICI SPA Approval
05/10/2023 FUROSEMIDE
NDA #018267		 SUPPL-27 FUROSEMIDE HIKMA Manufacturing (CMC) Approval
05/10/2023 FOSRENOL
NDA #021468		 SUPPL-26 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
05/10/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-9 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
05/10/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-10 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK PHARMS LTD Labeling Approval
05/10/2023 MONTELUKAST SODIUM
ANDA #090926		 SUPPL-12 MONTELUKAST SODIUM GLENMARK PHARMS LTD Labeling Approval
05/10/2023 MONTELUKAST SODIUM
ANDA #090926		 SUPPL-13 MONTELUKAST SODIUM GLENMARK PHARMS LTD Labeling Approval
05/10/2023 DICLOFENAC SODIUM
ANDA #204306		 SUPPL-6 DICLOFENAC SODIUM AUROLIFE PHARMA LLC Manufacturing (CMC) Approval
05/10/2023 FOSRENOL
NDA #204734		 SUPPL-8 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
05/10/2023 REXULTI
NDA #205422		 SUPPL-9 BREXPIPRAZOLE OTSUKA Efficacy Approval
05/10/2023 PROPYLTHIOURACIL
ANDA #208867		 ORIG-1 PROPYLTHIOURACIL MACLEODS PHARMS LTD Approval
05/10/2023 LINAGLIPTIN;METFORMIN HYDROCHLORIDE
ANDA #211921		 ORIG-1 LINAGLIPTIN;METFORMIN HYDROCHLORIDE SUN PHARM INDS LTD Tentative Approval
05/10/2023 VERQUVO
NDA #214377		 SUPPL-2 VERICIGUAT MERCK SHARP DOHME Labeling Approval
05/10/2023 METHYLPREDNISOLONE ACETATE
ANDA #214870		 SUPPL-1 METHYLPREDNISOLONE ACETATE SLAYBACK PHARMA LLC Manufacturing (CMC) Approval
05/10/2023 KETOROLAC TROMETHAMINE
ANDA #217789		 ORIG-1 KETOROLAC TROMETHAMINE CAPLIN Approval
05/11/2023 CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
NDA #021117		 SUPPL-25 CALCIUM CHLORIDE HOSPIRA Labeling Approval
05/11/2023 CALDOLOR
NDA #022348		 SUPPL-24 IBUPROFEN CUMBERLAND PHARMS Efficacy Approval
05/11/2023 CLINDAMYCIN PHOSPHATE
ANDA #064050		 SUPPL-22 CLINDAMYCIN PHOSPHATE PADAGIS US Labeling Approval
05/11/2023 IBUPROFEN
ANDA #072096		 SUPPL-103 IBUPROFEN PERRIGO Labeling Approval
05/11/2023 IBUPROFEN
ANDA #072096		 SUPPL-111 IBUPROFEN PERRIGO Manufacturing (CMC) Approval
05/11/2023 IBUPROFEN
ANDA #072096		 SUPPL-115 IBUPROFEN PERRIGO Labeling Approval
05/11/2023 VALACYCLOVIR HYDROCHLORIDE
ANDA #078518		 SUPPL-6 VALACYCLOVIR HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-13 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-15 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-16 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-19 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-20 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #091388		 SUPPL-22 QUETIAPINE FUMARATE AUROBINDO PHARMA LTD Labeling Approval
05/11/2023 COSENTYX
BLA #125504		 SUPPL-44 SECUKINUMAB NOVARTIS PHARMS CORP Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-14 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-15 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-16 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-18 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-20 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-23 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-26 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-10 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-12 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-14 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-16 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201190		 SUPPL-20 QUETIAPINE FUMARATE SUN PHARM Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-9 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-16 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-17 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-21 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-23 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-27 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #201504		 SUPPL-28 QUETIAPINE FUMARATE ALKEM LABS LTD Labeling Approval
05/11/2023 DOCETAXEL
ANDA #203892		 ORIG-1 DOCETAXEL MYLAN LABS LTD Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #206954		 SUPPL-2 QUETIAPINE FUMARATE PRINSTON INC Labeling Approval
05/11/2023 QUETIAPINE FUMARATE
ANDA #209635		 SUPPL-13 QUETIAPINE FUMARATE SCIEGEN PHARMS INC Labeling Approval
05/11/2023 LENALIDOMIDE
ANDA #212414		 ORIG-1 LENALIDOMIDE HETERO LABS LTD V Approval
05/11/2023 NITROFURANTOIN
ANDA #212607		 ORIG-1 NITROFURANTOIN AUROBINDO PHARMA Approval
05/11/2023 THEOPHYLLINE
ANDA #214113		 ORIG-1 THEOPHYLLINE RHODES PHARMS Approval
05/11/2023 ALENDRONATE SODIUM
ANDA #214512		 ORIG-1 ALENDRONATE SODIUM NOVITIUM PHARMA Approval
05/11/2023 CARMUSTINE
ANDA #214814		 ORIG-1 CARMUSTINE MSN Approval
05/11/2023 PACLITAXEL
NDA #216338		 ORIG-1 PACLITAXEL TEVA PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
05/11/2023 DICLOFENAC SODIUM
ANDA #216548		 ORIG-1 DICLOFENAC SODIUM RUBICON Approval
05/12/2023 CARAFATE
NDA #019183		 SUPPL-21 SUCRALFATE ABBVIE Labeling Approval
05/12/2023 LEXAPRO
NDA #021323		 SUPPL-55 ESCITALOPRAM OXALATE ABBVIE Efficacy Approval
05/12/2023 LEXAPRO
NDA #021365		 SUPPL-39 ESCITALOPRAM OXALATE ABBVIE Efficacy Approval
05/12/2023 LITHIUM CARBONATE
ANDA #076795		 SUPPL-15 LITHIUM CARBONATE APOTEX INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-2 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-3 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-6 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-7 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-8 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-11 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISPERIDONE
ANDA #079059		 SUPPL-15 RISPERIDONE TRIS PHARMA INC Labeling Approval
05/12/2023 RISEDRONATE SODIUM
ANDA #090877		 SUPPL-7 RISEDRONATE SODIUM APOTEX Labeling Approval
05/12/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #203332		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE INVENTIA HLTHCARE Labeling Approval
05/12/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #203332		 SUPPL-7 VENLAFAXINE HYDROCHLORIDE INVENTIA HLTHCARE Labeling Approval
05/12/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #203332		 SUPPL-9 VENLAFAXINE HYDROCHLORIDE INVENTIA HLTHCARE Labeling Approval
05/12/2023 AMMONIA N 13
ANDA #203543		 SUPPL-2 AMMONIA N-13 SOFIE Manufacturing (CMC) Approval
05/12/2023 BREO ELLIPTA
NDA #204275		 SUPPL-22 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Efficacy Approval
05/12/2023 EPINEPHRINE
NDA #205029		 SUPPL-10 EPINEPHRINE BPI LABS Manufacturing (CMC) Approval
05/12/2023 EVOTAZ
NDA #206353		 SUPPL-8 ATAZANAVIR SULFATE; COBICISTAT BRISTOL Labeling Approval
05/12/2023 ATORVASTATIN CALCIUM
ANDA #206536		 SUPPL-16 ATORVASTATIN CALCIUM ZYDUS PHARMS Labeling Approval
05/12/2023 CLOBAZAM
ANDA #209796		 SUPPL-2 CLOBAZAM HETERO LABS LTD III Labeling Approval
05/12/2023 ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE
ANDA #210642		 ORIG-1 ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE AUROBINDO PHARMA LTD Tentative Approval
05/12/2023 VEOZAH
NDA #216578		 ORIG-1 FEZOLINETANT ASTELLAS Type 1 - New Molecular Entity Approval
05/12/2023 MESALAMINE
ANDA #217337		 ORIG-1 MESALAMINE SINOTHERAPEUTICS INC Approval
05/12/2023 GABAPENTIN
ANDA #217546		 ORIG-1 GABAPENTIN LAURUS Approval
05/12/2023 TECENTRIQ
BLA #761034		 SUPPL-49 ATEZOLIZUMAB GENENTECH INC Approval
05/12/2023 TECENTRIQ
BLA #761034		 SUPPL-51 ATEZOLIZUMAB GENENTECH INC Approval
05/15/2023 EXCEDRIN (MIGRAINE RELIEF)
NDA #020802		 SUPPL-42 ACETAMINOPHEN; ASPIRIN; CAFFEINE HALEON US HOLDINGS Manufacturing (CMC) Approval
05/15/2023 DOCETAXEL
NDA #022234		 SUPPL-22 DOCETAXEL HOSPIRA INC Labeling Approval
05/15/2023 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-13 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
05/15/2023 ONDANSETRON HYDROCHLORIDE
ANDA #077545		 SUPPL-14 ONDANSETRON HYDROCHLORIDE HIKMA INTL PHARMS Labeling Approval
05/15/2023 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-13 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
05/15/2023 IRINOTECAN HYDROCHLORIDE
ANDA #077915		 SUPPL-14 IRINOTECAN HYDROCHLORIDE HOSPIRA Labeling Approval
05/15/2023 POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ANDA #078446		 SUPPL-8 POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Labeling Approval
05/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203290		 SUPPL-1 OMEPRAZOLE; SODIUM BICARBONATE ZYDUS PHARMS Labeling Approval
05/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203290		 SUPPL-3 OMEPRAZOLE; SODIUM BICARBONATE ZYDUS PHARMS Labeling Approval
05/15/2023 OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203290		 SUPPL-4 OMEPRAZOLE; SODIUM BICARBONATE ZYDUS PHARMS Labeling Approval
05/15/2023 METHENAMINE HIPPURATE
ANDA #205661		 SUPPL-1 METHENAMINE HIPPURATE AUROBINDO PHARMA LTD Labeling Approval
05/15/2023 METHENAMINE HIPPURATE
ANDA #205661		 SUPPL-3 METHENAMINE HIPPURATE AUROBINDO PHARMA LTD Labeling Approval
05/15/2023 FULVESTRANT
ANDA #205871		 SUPPL-6 FULVESTRANT SAGENT PHARMS INC Labeling Approval
05/15/2023 FULVESTRANT
ANDA #205871		 SUPPL-9 FULVESTRANT SAGENT PHARMS INC Labeling Approval
05/15/2023 FULVESTRANT
ANDA #205871		 SUPPL-10 FULVESTRANT SAGENT PHARMS INC Labeling Approval
05/15/2023 MELPHALAN HYDROCHLORIDE
ANDA #206018		 SUPPL-2 MELPHALAN HYDROCHLORIDE ACTAVIS LLC Labeling Approval
05/15/2023 FIRDAPSE
NDA #208078		 SUPPL-9 AMIFAMPRIDINE PHOSPHATE CATALYST PHARMS Labeling Approval
05/15/2023 TERIFLUNOMIDE
ANDA #209555		 ORIG-1 TERIFLUNOMIDE NATCO Approval
05/15/2023 VIVIMUSTA
NDA #212209		 SUPPL-3 BENDAMUSTINE HYDROCHLORIDE SLAYBACK PHARMA LLC Labeling Approval
05/15/2023 NALOXONE HYDROCHLORIDE
ANDA #212300		 SUPPL-3 NALOXONE HYDROCHLORIDE HIKMA Labeling Approval
05/15/2023 INREBIC
NDA #212327		 SUPPL-5 FEDRATINIB HYDROCHLORIDE BRISTOL-MYERS Labeling Approval
05/15/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #216349		 SUPPL-2 ESOMEPRAZOLE MAGNESIUM GRAVITI PHARMS Labeling Approval
05/15/2023 FAMOTIDINE
ANDA #216400		 ORIG-1 FAMOTIDINE ALKEM LABS LTD Approval
05/15/2023 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #216604		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE AMNEAL Approval
05/15/2023 NALOXONE HYDROCHLORIDE
ANDA #216624		 SUPPL-1 NALOXONE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/15/2023 RUFINAMIDE
ANDA #216688		 ORIG-1 RUFINAMIDE MICRO LABS Approval
05/16/2023 NALOXONE HYDROCHLORIDE
ANDA #072076		 SUPPL-22 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
05/16/2023 NALOXONE HYDROCHLORIDE
ANDA #072076		 SUPPL-24 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
05/16/2023 AMINOPHYLLINE
ANDA #087600		 SUPPL-28 AMINOPHYLLINE AM REGENT Manufacturing (CMC) Approval
05/16/2023 DAPTOMYCIN
ANDA #206077		 SUPPL-4 DAPTOMYCIN FRESENIUS KABI USA Labeling Approval
05/16/2023 DAPTOMYCIN
ANDA #206077		 SUPPL-6 DAPTOMYCIN FRESENIUS KABI USA Labeling Approval
05/16/2023 DAPTOMYCIN
ANDA #206077		 SUPPL-9 DAPTOMYCIN FRESENIUS KABI USA Labeling Approval
05/16/2023 FOSAPREPITANT DIMEGLUMINE
ANDA #214683		 ORIG-1 FOSAPREPITANT DIMEGLUMINE PIRAMAL CRITICAL Approval
05/16/2023 FENOPROFEN CALCIUM
ANDA #215548		 ORIG-1 FENOPROFEN CALCIUM MISEMER Approval
05/16/2023 NALOXONE HYDROCHLORIDE
ANDA #215964		 SUPPL-1 NALOXONE HYDROCHLORIDE PAR STERILE PRODUCTS Labeling Approval
05/16/2023 METHYLNALTREXONE BROMIDE
ANDA #216965		 ORIG-1 METHYLNALTREXONE BROMIDE GLAND PHARMA LTD Tentative Approval
05/16/2023 EPHEDRINE SULFATE
ANDA #217276		 ORIG-1 EPHEDRINE SULFATE ZYDUS PHARMS Approval
05/17/2023 INTRALIPID 10%
NDA #017643		 SUPPL-83 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 INTRALIPID 20%
NDA #018449		 SUPPL-50 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 INTRALIPID 20%
NDA #018449		 SUPPL-51 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 NUTRILIPID 10%
NDA #019531		 SUPPL-13 SOYBEAN OIL B BRAUN Manufacturing (CMC) Approval
05/17/2023 NUTRILIPID 10%
NDA #019531		 SUPPL-16 SOYBEAN OIL B BRAUN Labeling Approval
05/17/2023 NUTRILIPID 20%
NDA #019531		 SUPPL-13 SOYBEAN OIL B BRAUN Manufacturing (CMC) Approval
05/17/2023 NUTRILIPID 20%
NDA #019531		 SUPPL-16 SOYBEAN OIL B BRAUN Labeling Approval
05/17/2023 INTRALIPID 30%
NDA #019942		 SUPPL-21 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 INTRALIPID 20%
NDA #020248		 SUPPL-27 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 INTRALIPID 20%
NDA #020248		 SUPPL-28 SOYBEAN OIL FRESENIUS Labeling Approval
05/17/2023 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-49 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
05/17/2023 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-50 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
05/17/2023 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ANDA #089534		 SUPPL-55 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
05/17/2023 LEVETIRACETAM
ANDA #090876		 SUPPL-3 LEVETIRACETAM FRESENIUS KABI USA Labeling Approval
05/17/2023 LEVETIRACETAM
ANDA #090876		 SUPPL-4 LEVETIRACETAM FRESENIUS KABI USA Labeling Approval
05/17/2023 KABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-18 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Labeling Approval
05/17/2023 PERIKABIVEN IN PLASTIC CONTAINER
NDA #200656		 SUPPL-18 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL FRESENIUS KABI USA Labeling Approval
05/17/2023 CLINOLIPID 20%
NDA #204508		 SUPPL-19 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Labeling Approval
05/17/2023 CLINOLIPID 20%
NDA #204508		 SUPPL-21 OLIVE OIL; SOYBEAN OIL BAXTER HLTHCARE CORP Labeling Approval
05/17/2023 BRIVIACT
NDA #205836		 SUPPL-14 BRIVARACETAM UCB INC Labeling Approval
05/17/2023 BRIVIACT
NDA #205837		 SUPPL-11 BRIVARACETAM UCB INC Labeling Approval
05/17/2023 BRIVIACT
NDA #205838		 SUPPL-11 BRIVARACETAM UCB INC Labeling Approval
05/17/2023 SMOFLIPID 20%
NDA #207648		 SUPPL-10 FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL FRESENIUS KABI USA Labeling Approval
05/17/2023 ISOSULFAN BLUE
ANDA #210294		 ORIG-1 ISOSULFAN BLUE AM REGENT Approval
05/17/2023 OMEGAVEN
NDA #210589		 SUPPL-3 FISH OIL TRIGLYCERIDES FRESENIUS KABI USA Labeling Approval
05/18/2023 FEMHRT
NDA #021065		 SUPPL-25 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
05/18/2023 FEMHRT
NDA #021065		 SUPPL-26 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065136		 SUPPL-20 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065136		 SUPPL-22 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065136		 SUPPL-25 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065136		 SUPPL-27 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065136		 SUPPL-29 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065144		 SUPPL-19 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065144		 SUPPL-21 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065144		 SUPPL-24 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065144		 SUPPL-26 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 CLARITHROMYCIN
ANDA #065144		 SUPPL-28 CLARITHROMYCIN SANDOZ Labeling Approval
05/18/2023 NALOXONE HYDROCHLORIDE
ANDA #070639		 SUPPL-19 NALOXONE HYDROCHLORIDE INTL MEDICATION Labeling Approval
05/18/2023 IMBRUVICA
NDA #205552		 SUPPL-40 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
05/18/2023 IMBRUVICA
NDA #210563		 SUPPL-17 IBRUTINIB PHARMACYCLICS LLC Efficacy Approval
05/18/2023 RINVOQ
NDA #211675		 SUPPL-15 UPADACITINIB ABBVIE Efficacy Approval
05/18/2023 MIEBO
NDA #216675		 ORIG-1 PERFLUOROHEXYLOCTANE BAUSCH AND LOMB INC Type 1 - New Molecular Entity Approval
05/18/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #217390		 ORIG-1 VENLAFAXINE HYDROCHLORIDE GRANULES Approval
05/18/2023 CYLTEZO
BLA #761058		 SUPPL-16 ADALIMUMAB-ADBM BOEHRINGER INGELHEIM Approval
05/19/2023 CLOZARIL
NDA #019758		 SUPPL-103 CLOZAPINE HERITAGE LIFE Labeling Approval
05/19/2023 YASMIN
NDA #021098		 SUPPL-29 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Labeling Approval
05/19/2023 YAZ
NDA #021676		 SUPPL-20 DROSPIRENONE; ETHINYL ESTRADIOL BAYER HLTHCARE Labeling Approval
05/19/2023 BEYAZ
NDA #022532		 SUPPL-10 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BAYER HLTHCARE Labeling Approval
05/19/2023 SAFYRAL
NDA #022574		 SUPPL-10 DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM BAYER HLTHCARE Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090263		 SUPPL-11 LEVETIRACETAM CHARTWELL MOLECULAR Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090263		 SUPPL-12 LEVETIRACETAM CHARTWELL MOLECULAR Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090263		 SUPPL-13 LEVETIRACETAM CHARTWELL MOLECULAR Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090263		 SUPPL-14 LEVETIRACETAM CHARTWELL MOLECULAR Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090263		 SUPPL-15 LEVETIRACETAM CHARTWELL MOLECULAR Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090992		 SUPPL-5 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090992		 SUPPL-6 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090992		 SUPPL-7 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090992		 SUPPL-8 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
05/19/2023 LEVETIRACETAM
ANDA #090992		 SUPPL-9 LEVETIRACETAM AMNEAL PHARMS Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-7 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-8 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-9 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-10 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-11 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-12 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-13 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #200158		 SUPPL-14 DICLOFENAC SODIUM; MISOPROSTOL SANDOZ Labeling Approval
05/19/2023 LAMOTRIGINE
ANDA #200672		 SUPPL-12 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
05/19/2023 LAMOTRIGINE
ANDA #200672		 SUPPL-13 LAMOTRIGINE ACTAVIS ELIZABETH Labeling Approval
05/19/2023 ZOLEDRONIC ACID
ANDA #202923		 SUPPL-7 ZOLEDRONIC ACID USV Labeling Approval
05/19/2023 ZOLEDRONIC ACID
ANDA #202923		 SUPPL-14 ZOLEDRONIC ACID USV Labeling Approval
05/19/2023 MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
ANDA #205833		 SUPPL-9 MOXIFLOXACIN HYDROCHLORIDE MYLAN LABS LTD Labeling Approval
05/19/2023 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #205876		 SUPPL-3 DROSPIRENONE; ETHINYL ESTRADIOL APOTEX Labeling Approval
05/19/2023 DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #205876		 SUPPL-6 DROSPIRENONE; ETHINYL ESTRADIOL APOTEX Labeling Approval
05/19/2023 TETRABENAZINE
ANDA #206093		 SUPPL-1 TETRABENAZINE APOTEX Labeling Approval
05/19/2023 SEVELAMER CARBONATE
ANDA #206094		 SUPPL-3 SEVELAMER CARBONATE DR REDDYS Labeling Approval
05/19/2023 SEVELAMER CARBONATE
ANDA #206094		 SUPPL-5 SEVELAMER CARBONATE DR REDDYS Labeling Approval
05/19/2023 ALISKIREN HEMIFUMARATE
ANDA #206665		 SUPPL-2 ALISKIREN HEMIFUMARATE ANCHEN PHARMS Labeling Approval
05/19/2023 ACETAZOLAMIDE
ANDA #207401		 SUPPL-1 ACETAZOLAMIDE MICRO LABS LTD INDIA Labeling Approval
05/19/2023 ACETAZOLAMIDE
ANDA #207659		 SUPPL-3 ACETAZOLAMIDE ACCORD HLTHCARE Labeling Approval
05/19/2023 DEFERASIROX
ANDA #209433		 SUPPL-1 DEFERASIROX ICHNOS Labeling Approval
05/19/2023 DEFERASIROX
ANDA #209433		 SUPPL-2 DEFERASIROX ICHNOS Labeling Approval
05/19/2023 COLCHICINE
ANDA #210425		 SUPPL-2 COLCHICINE GRANULES Labeling Approval
05/19/2023 CARBOPROST TROMETHAMINE
ANDA #216824		 ORIG-1 CARBOPROST TROMETHAMINE SOLA PHARMS Approval
05/19/2023 AMITRIPTYLINE HYDROCHLORIDE
ANDA #217411		 ORIG-1 AMITRIPTYLINE HYDROCHLORIDE RISING Approval
05/19/2023 EPKINLY
BLA #761324		 ORIG-1 EPCORITAMAB-BYSP GENMAB US, INC. Approval
05/22/2023 LEVETIRACETAM
ANDA #201157		 SUPPL-8 LEVETIRACETAM PHARM ASSOC Labeling Approval
05/22/2023 HYDROMORPHONE HYDROCHLORIDE
ANDA #204278		 SUPPL-17 HYDROMORPHONE HYDROCHLORIDE PADAGIS US Labeling Approval
05/22/2023 LEVETIRACETAM
ANDA #204312		 SUPPL-9 LEVETIRACETAM EUGIA PHARMA Labeling Approval
05/22/2023 ITRACONAZOLE
ANDA #206741		 SUPPL-14 ITRACONAZOLE ALEMBIC Labeling Approval
05/22/2023 RYDAPT
NDA #207997		 SUPPL-10 MIDOSTAURIN NOVARTIS Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209647		 SUPPL-4 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209647		 SUPPL-5 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209647		 SUPPL-7 ESOMEPRAZOLE MAGNESIUM AMNEAL PHARMS NY Labeling Approval
05/22/2023 CLOBAZAM
ANDA #209718		 SUPPL-4 CLOBAZAM AMNEAL PHARMS CO Labeling Approval
05/22/2023 CLOBAZAM
ANDA #209718		 SUPPL-9 CLOBAZAM AMNEAL PHARMS CO Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209735		 SUPPL-9 ESOMEPRAZOLE MAGNESIUM SUN PHARM Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209735		 SUPPL-11 ESOMEPRAZOLE MAGNESIUM SUN PHARM Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #209735		 SUPPL-13 ESOMEPRAZOLE MAGNESIUM SUN PHARM Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #210559		 SUPPL-3 ESOMEPRAZOLE MAGNESIUM INDCHEMIE HEALTH Labeling Approval
05/22/2023 ESOMEPRAZOLE MAGNESIUM
ANDA #210559		 SUPPL-6 ESOMEPRAZOLE MAGNESIUM INDCHEMIE HEALTH Labeling Approval
05/22/2023 CLOBAZAM
ANDA #210746		 SUPPL-7 CLOBAZAM VISTAPHARM Labeling Approval
05/22/2023 CLOBAZAM
ANDA #210978		 SUPPL-6 CLOBAZAM TARO Labeling Approval
05/22/2023 LEVETIRACETAM
ANDA #211954		 SUPPL-1 LEVETIRACETAM MICRO LABS Labeling Approval
05/22/2023 LEVETIRACETAM
ANDA #211954		 SUPPL-2 LEVETIRACETAM MICRO LABS Labeling Approval
05/22/2023 AYVAKIT
NDA #212608		 SUPPL-13 AVAPRITINIB BLUEPRINT MEDICINES Efficacy Approval
05/22/2023 VIGPODER
ANDA #214961		 SUPPL-2 VIGABATRIN PYROS PHARMS Labeling Approval
05/22/2023 PEMETREXED
NDA #215179		 ORIG-1 PEMETREXED DISODIUM SHILPA Type 5 - New Formulation or New Manufacturer Approval
05/22/2023 LEVOLEUCOVORIN CALCIUM
ANDA #217314		 ORIG-1 LEVOLEUCOVORIN CALCIUM HAINAN POLY PHARM Approval
05/22/2023 OPVEE
NDA #217470		 ORIG-1 NALMEFENE HYDROCHLORIDE INDIVIOR Type 3 - New Dosage Form Approval
05/23/2023 CHORIONIC GONADOTROPIN
BLA #017016		 SUPPL-172 GONADOTROPIN, CHORIONIC FERRING Approval
05/23/2023 DIVIGEL
NDA #022038		 SUPPL-10 ESTRADIOL VERTICAL PHARMS Labeling Approval
05/23/2023 ROPIVACAINE HYDROCHLORIDE
ANDA #090194		 SUPPL-2 ROPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
05/23/2023 ROPIVACAINE HYDROCHLORIDE
ANDA #090194		 SUPPL-5 ROPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
05/23/2023 BACLOFEN
ANDA #090334		 SUPPL-3 BACLOFEN APPCO Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-4 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-5 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-6 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-8 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-9 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-10 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 GABAPENTIN
ANDA #090335		 SUPPL-11 GABAPENTIN MYLAN PHARMS INC Labeling Approval
05/23/2023 SIMVASTATIN
ANDA #090383		 SUPPL-12 SIMVASTATIN MICRO LABS Labeling Approval
05/23/2023 SIMVASTATIN
ANDA #090383		 SUPPL-13 SIMVASTATIN MICRO LABS Labeling Approval
05/23/2023 SIMVASTATIN
ANDA #090383		 SUPPL-14 SIMVASTATIN MICRO LABS Labeling Approval
05/23/2023 SIMVASTATIN
ANDA #090383		 SUPPL-15 SIMVASTATIN MICRO LABS Labeling Approval
05/23/2023 EXEMESTANE
ANDA #200898		 SUPPL-12 EXEMESTANE ALVOGEN Labeling Approval
05/23/2023 ZOLMITRIPTAN
ANDA #202279		 SUPPL-5 ZOLMITRIPTAN JUBILANT GENERICS Labeling Approval
05/23/2023 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
ANDA #203580		 SUPPL-18 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL TORRENT Labeling Approval
05/23/2023 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954		 SUPPL-15 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALVOGEN Labeling Approval
05/23/2023 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954		 SUPPL-21 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALVOGEN Labeling Approval
05/23/2023 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954		 SUPPL-23 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALVOGEN Labeling Approval
05/23/2023 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #206880		 SUPPL-7 LEVETIRACETAM GLAND PHARMA LTD Labeling Approval
05/23/2023 LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160		 SUPPL-5 LEVETIRACETAM EUGIA PHARMA Labeling Approval
05/23/2023 BRIXADI
NDA #210136		 ORIG-1 BUPRENORPHINE BRAEBURN Type 3 - New Dosage Form Approval
05/23/2023 FEXOFENADINE HYDROCHLORIDE
ANDA #213466		 ORIG-1 FEXOFENADINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
05/23/2023 METHYLPHENIDATE HYDROCHLORIDE
ANDA #214447		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALKEM LABS LTD Approval
05/23/2023 HALOPERIDOL DECANOATE
ANDA #216730		 ORIG-1 HALOPERIDOL DECANOATE MANKIND PHARMA Approval
05/23/2023 TOFACITINIB
ANDA #216770		 ORIG-1 TOFACITINIB TEVA PHARMS INC Tentative Approval
05/23/2023 XACDURO (COPACKAGED)
NDA #216974		 ORIG-1 DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM ENTASIS THERAP Type 1 - New Molecular Entity and Type 4 - New Combination Approval
05/23/2023 REGADENOSON
ANDA #217455		 ORIG-1 REGADENOSON BAXTER HLTHCARE CORP Approval
05/23/2023 YUFLYMA
BLA #761219		 ORIG-1 ADALIMUMAB-AATY CELLTRION Approval
05/24/2023 RISEDRONATE SODIUM
ANDA #079215		 SUPPL-4 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
05/24/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #083745		 SUPPL-123 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
05/24/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #084936		 SUPPL-109 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
05/24/2023 IMIPRAMINE HYDROCHLORIDE
ANDA #084937		 SUPPL-129 IMIPRAMINE HYDROCHLORIDE SANDOZ Labeling Approval
05/24/2023 NORETHINDRONE
ANDA #091209		 SUPPL-10 NORETHINDRONE GLENMARK PHARMS LTD Labeling Approval
05/24/2023 LUMIZYME
BLA #125291		 SUPPL-159 ALGLUCOSIDASE ALFA GENZYME Approval
05/24/2023 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA #202934		 SUPPL-1 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE ACTAVIS ELIZABETH Labeling Approval
05/24/2023 ACETAZOLAMIDE
ANDA #205530		 SUPPL-11 ACETAZOLAMIDE HERITAGE PHARMA Labeling Approval
05/24/2023 OXYBUTYNIN CHLORIDE
ANDA #206121		 SUPPL-6 OXYBUTYNIN CHLORIDE UNIQUE Labeling Approval
05/24/2023 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #206845		 SUPPL-8 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/24/2023 ONDANSETRON HYDROCHLORIDE
ANDA #206846		 SUPPL-8 ONDANSETRON HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
05/24/2023 READYPREP CHG
NDA #207964		 SUPPL-3 CHLORHEXIDINE GLUCONATE MEDLINE INDUSTRIES Manufacturing (CMC) Approval
05/24/2023 METHIMAZOLE
ANDA #209827		 ORIG-1 METHIMAZOLE MACLEODS PHARMS LTD Approval
05/24/2023 FINGOLIMOD HYDROCHLORIDE
ANDA #210252		 ORIG-1 FINGOLIMOD HYDROCHLORIDE BIONPHARMA Approval
05/24/2023 VENLAFAXINE HYDROCHLORIDE
ANDA #214419		 SUPPL-1 VENLAFAXINE HYDROCHLORIDE ASCENT PHARMS INC Labeling Approval
05/24/2023 NASONEX 24HR ALLERGY
NDA #215712		 SUPPL-15 MOMETASONE FUROATE PERRIGO PHARMA INTL Labeling Approval
05/24/2023 TOFACITINIB
ANDA #216940		 ORIG-1 TOFACITINIB HEILONGJIANG ZBD PHARMACEUTICAL CO LTD Tentative Approval
05/24/2023 ROCURONIUM BROMIDE
ANDA #217034		 ORIG-1 ROCURONIUM BROMIDE HIKMA Approval
05/24/2023 METRONIDAZOLE IN PLASTIC CONTAINER
ANDA #217665		 ORIG-1 METRONIDAZOLE AMNEAL Approval
05/25/2023 ULTRAVIST 150
NDA #020220		 SUPPL-54 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 ULTRAVIST 240
NDA #020220		 SUPPL-54 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 ULTRAVIST 300
NDA #020220		 SUPPL-54 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 ULTRAVIST 300 IN PLASTIC CONTAINER
NDA #020220		 SUPPL-54 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 ULTRAVIST 370
NDA #020220		 SUPPL-54 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 CLARITIN HIVES RELIEF REDITAB
NDA #020704		 SUPPL-41 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
05/25/2023 CLARITIN REDITABS
NDA #020704		 SUPPL-41 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
05/25/2023 ULTRAVIST (PHARMACY BULK)
NDA #021425		 SUPPL-36 IOPROMIDE BAYER HLTHCARE Efficacy Approval
05/25/2023 CLARITIN REDITABS
NDA #021993		 SUPPL-23 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
05/25/2023 SUSTOL
NDA #022445		 SUPPL-10 GRANISETRON HERON THERAPS INC Labeling Approval
05/25/2023 TOPIRAMATE
ANDA #078235		 SUPPL-32 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
05/25/2023 TOPIRAMATE
ANDA #078235		 SUPPL-33 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
05/25/2023 TOPIRAMATE
ANDA #078877		 SUPPL-22 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
05/25/2023 TOPIRAMATE
ANDA #078877		 SUPPL-24 TOPIRAMATE ZYDUS PHARMS USA INC Labeling Approval
05/25/2023 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-44 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
05/25/2023 PALONOSETRON HYDROCHLORIDE
ANDA #205870		 SUPPL-3 PALONOSETRON HYDROCHLORIDE SAGENT PHARMS INC Labeling Approval
05/25/2023 EPTIFIBATIDE
ANDA #206127		 SUPPL-4 EPTIFIBATIDE EUGIA PHARMA Labeling Approval
05/25/2023 BUDESONIDE
ANDA #206623		 SUPPL-3 BUDESONIDE DR REDDYS LABS SA Labeling Approval
05/25/2023 BUDESONIDE
ANDA #206623		 SUPPL-4 BUDESONIDE DR REDDYS LABS SA Labeling Approval
05/25/2023 BUDESONIDE
ANDA #206623		 SUPPL-9 BUDESONIDE DR REDDYS LABS SA Manufacturing (CMC) Approval
05/25/2023 TRIAZOLAM
ANDA #213003		 SUPPL-1 TRIAZOLAM ZYDUS PHARMS Labeling Approval
05/25/2023 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #214065		 SUPPL-5 CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE ALKEM LABS LTD Labeling Approval
05/25/2023 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #214930		 SUPPL-9 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALKEM LABS LTD Labeling Approval
05/25/2023 POSLUMA
NDA #216023		 ORIG-1 FLOTUFOLASTAT F-18 GALLIUM BLUE EARTH Type 1 - New Molecular Entity Approval
05/25/2023 NITISINONE
ANDA #216201		 ORIG-1 NITISINONE ETON Approval
05/25/2023 CARBOPROST TROMETHAMINE
ANDA #216939		 ORIG-1 CARBOPROST TROMETHAMINE EUGIA PHARMA Approval
05/25/2023 PAXLOVID (COPACKAGED)
NDA #217188		 ORIG-1 NIRMATRELVIR; RITONAVIR PFIZER Type 1 - New Molecular Entity Approval
05/25/2023 MARGENZA
BLA #761150		 SUPPL-5 MARGETUXIMAB-CMKB MACROGENICS INC Approval
05/26/2023 ITRACONAZOLE
ANDA #076104		 SUPPL-24 ITRACONAZOLE SANDOZ Labeling Approval
05/26/2023 METOPROLOL SUCCINATE
ANDA #078889		 SUPPL-14 METOPROLOL SUCCINATE REDDYS Labeling Approval
05/26/2023 METOPROLOL SUCCINATE
ANDA #078889		 SUPPL-17 METOPROLOL SUCCINATE REDDYS Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-3 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-4 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-6 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-8 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-9 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 LEVETIRACETAM
ANDA #090981		 SUPPL-12 LEVETIRACETAM HIKMA FARMACEUTICA Labeling Approval
05/26/2023 TAFINLAR
NDA #202806		 SUPPL-26 DABRAFENIB MESYLATE NOVARTIS Labeling Approval
05/26/2023 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #202870		 SUPPL-15 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE ALEMBIC Labeling Approval
05/26/2023 METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
ANDA #202870		 SUPPL-18 HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE ALEMBIC Labeling Approval
05/26/2023 MEKINIST
NDA #204114		 SUPPL-28 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Labeling Approval
05/26/2023 OPSUMIT
NDA #204410		 SUPPL-24 MACITENTAN ACTELION Labeling Approval
05/26/2023 ITRACONAZOLE
ANDA #205724		 SUPPL-5 ITRACONAZOLE PAR PHARM INC Labeling Approval
05/26/2023 SEVELAMER HYDROCHLORIDE
ANDA #206883		 ORIG-1 SEVELAMER HYDROCHLORIDE MACLEODS PHARMS LTD Approval
05/26/2023 ITRACONAZOLE
ANDA #209460		 SUPPL-4 ITRACONAZOLE TORRENT Labeling Approval
05/26/2023 APIXABAN
ANDA #210026		 ORIG-1 APIXABAN AUROBINDO PHARMA LTD Approval
05/26/2023 ITRACONAZOLE
ANDA #212239		 SUPPL-1 ITRACONAZOLE ANNORA PHARMA Labeling Approval
05/26/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #212797		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE XIAMEN LP PHARM CO Labeling Approval
05/26/2023 VASOPRESSIN
ANDA #213205		 ORIG-1 VASOPRESSIN FRESENIUS KABI USA Tentative Approval
05/26/2023 VASOPRESSIN
ANDA #213206		 ORIG-1 VASOPRESSIN FRESENIUS KABI USA Approval
05/26/2023 METFORMIN HYDROCHLORIDE
ANDA #213320		 SUPPL-2 METFORMIN HYDROCHLORIDE HARMAN FINOCHEM Manufacturing (CMC) Approval
05/26/2023 DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE
NDA #215448		 ORIG-1 DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE AUROBINDO PHARMA USA Type 4 - New Combination Tentative Approval
05/26/2023 INPEFA
NDA #216203		 ORIG-1 SOTAGLIFLOZIN LEXICON PHARMS INC Type 1 - New Molecular Entity Approval
05/26/2023 TIMOLOL MALEATE
ANDA #217343		 ORIG-1 TIMOLOL MALEATE MICRO LABS Approval
05/26/2023 ZINPLAVA
BLA #761046		 SUPPL-12 BEZLOTOXUMAB MERCK SHARP DOHME Approval
05/26/2023 TEZSPIRE
BLA #761224		 SUPPL-3 TEZEPELUMAB-EKKO ASTRAZENECA AB Approval
05/28/2023 AZITHROMYCIN
ANDA #065246		 SUPPL-30 AZITHROMYCIN PLIVA Labeling Approval
05/28/2023 ALBUTEROL SULFATE
ANDA #207857		 SUPPL-8 ALBUTEROL SULFATE SUN PHARM Labeling Approval
05/30/2023 DIAZEPAM
ANDA #091076		 ORIG-1 DIAZEPAM NOVEL LABS INC Approval
05/30/2023 JENCYCLA
ANDA #091323		 SUPPL-8 NORETHINDRONE LUPIN LTD Labeling Approval
05/30/2023 BANZEL
NDA #201367		 SUPPL-11 RUFINAMIDE EISAI INC Manufacturing (CMC) Approval
05/30/2023 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-22 QUETIAPINE FUMARATE UNICHEM Labeling Approval
05/30/2023 FINTEPLA
NDA #212102		 SUPPL-9 FENFLURAMINE HYDROCHLORIDE UCB INC REMS Approval
05/30/2023 CISATRACURIUM BESYLATE
ANDA #212190		 SUPPL-2 CISATRACURIUM BESYLATE PIRAMAL HLTHCARE UK Labeling Approval
05/30/2023 CISATRACURIUM BESYLATE
ANDA #212190		 SUPPL-4 CISATRACURIUM BESYLATE PIRAMAL HLTHCARE UK Labeling Approval
05/30/2023 CISATRACURIUM BESYLATE
ANDA #212432		 SUPPL-1 CISATRACURIUM BESYLATE PIRAMAL HLTHCARE UK Labeling Approval
05/30/2023 CISATRACURIUM BESYLATE
ANDA #212432		 SUPPL-3 CISATRACURIUM BESYLATE PIRAMAL HLTHCARE UK Labeling Approval
05/30/2023 OBETICHOLIC ACID
ANDA #214862		 ORIG-1 OBETICHOLIC ACID APOTEX Approval
05/30/2023 OBETICHOLIC ACID
ANDA #214980		 ORIG-1 OBETICHOLIC ACID LUPIN LTD Approval
05/30/2023 OBETICHOLIC ACID
ANDA #215017		 ORIG-1 OBETICHOLIC ACID MSN Approval
05/30/2023 MESALAMINE
ANDA #216941		 ORIG-1 MESALAMINE ENCUBE Approval
05/30/2023 VEVYE
NDA #217469		 ORIG-1 CYCLOSPORINE HARROW EYE Type 5 - New Formulation or New Manufacturer Approval
05/30/2023 SEMGLEE
BLA #761201		 SUPPL-7 INSULIN GLARGINE-YFGN MYLAN PHARMS INC Approval
05/31/2023 CLARITIN
NDA #021952		 SUPPL-22 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
05/31/2023 NALOXONE HYDROCHLORIDE
ANDA #070172		 SUPPL-31 NALOXONE HYDROCHLORIDE HOSPIRA Labeling Approval
05/31/2023 INJECTAFER
NDA #203565		 SUPPL-20 FERRIC CARBOXYMALTOSE AM REGENT Efficacy Approval
05/31/2023 INJECTAFER
NDA #203565		 SUPPL-24 FERRIC CARBOXYMALTOSE AM REGENT Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-2 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-5 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-9 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-13 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-18 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 CLARITHROMYCIN
ANDA #203584		 SUPPL-20 CLARITHROMYCIN HEC PHARM Labeling Approval
05/31/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #203615		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-3 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-4 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-5 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-6 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-7 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-12 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-15 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #203874		 SUPPL-16 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM DR REDDYS Labeling Approval
05/31/2023 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #204518		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC Labeling Approval
05/31/2023 COTELLIC
NDA #206192		 SUPPL-6 COBIMETINIB FUMARATE GENENTECH INC Labeling Approval
05/31/2023 LYNPARZA
NDA #208558		 SUPPL-25 OLAPARIB ASTRAZENECA Efficacy Approval
05/31/2023 DAPSONE
ANDA #212701		 ORIG-1 DAPSONE AMNEAL Approval
05/31/2023 PIRFENIDONE
ANDA #212709		 ORIG-1 PIRFENIDONE APOTEX Approval
05/31/2023 GEFITINIB
ANDA #212827		 ORIG-1 GEFITINIB NATCO Approval
05/31/2023 BUPROPION HYDROCHLORIDE
ANDA #216800		 ORIG-1 BUPROPION HYDROCHLORIDE ANNORA PHARMA Approval
05/31/2023 NAPROXEN
ANDA #216908		 ORIG-1 NAPROXEN TULEX PHARMS INC Approval
Back to Top