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
June 2026

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 June 12, 2026.

 

< Previous Month     Next Month >
Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2026 AFINITOR
NDA #022334		 SUPPL-55 EVEROLIMUS NOVARTIS Labeling Approval
06/01/2026 DIAZEPAM
ANDA #070311		 SUPPL-28 DIAZEPAM HIKMA Manufacturing (CMC) Approval
06/01/2026 SOLIRIS
BLA #125166		 SUPPL-453 ECULIZUMAB ALEXION PHARM Approval
06/01/2026 AFINITOR DISPERZ
NDA #203985		 SUPPL-28 EVEROLIMUS NOVARTIS PHARM Labeling Approval
06/01/2026 METHYLPREDNISOLONE
ANDA #206751		 SUPPL-10 METHYLPREDNISOLONE ZYDUS PHARMS Labeling Approval
06/01/2026 LURASIDONE HYDROCHLORIDE
ANDA #208047		 SUPPL-3 LURASIDONE HYDROCHLORIDE DR REDDYS Labeling Approval
06/01/2026 LURASIDONE HYDROCHLORIDE
ANDA #208047		 SUPPL-4 LURASIDONE HYDROCHLORIDE DR REDDYS Labeling Approval
06/01/2026 OZEMPIC
NDA #209637		 SUPPL-38 SEMAGLUTIDE NOVO Labeling Approval
06/01/2026 ERIBULIN MESYLATE
ANDA #217085		 ORIG-1 ERIBULIN MESYLATE NATCO Approval
06/01/2026 PHYTONADIONE
ANDA #217734		 ORIG-1 PHYTONADIONE AMNEAL Approval
06/01/2026 MYCOPHENOLATE MOFETIL
ANDA #218566		 ORIG-1 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD Approval
06/01/2026 FLUORESCEIN SODIUM
ANDA #218651		 ORIG-1 FLUORESCEIN SODIUM ZYDUS LIFESCIENCES Approval
06/01/2026 CYCLOSPORINE
ANDA #219288		 ORIG-1 CYCLOSPORINE JIANGSU ANBISON Approval
06/01/2026 PEMIGATINIB
ANDA #219552		 ORIG-1 PEMIGATINIB SANDOZ INC Tentative Approval
06/01/2026 BELZUTIFAN
ANDA #220866		 ORIG-1 BELZUTIFAN HETERO LABS LIMITED Tentative Approval
06/01/2026 ULTOMIRIS
BLA #761108		 SUPPL-45 RAVULIZUMAB-CWVZ ALEXION PHARM Approval
06/02/2026 FUROSEMIDE
NDA #018569		 SUPPL-71 FUROSEMIDE EPIC PHARMA LLC Labeling Approval
06/02/2026 LEFLUNOMIDE
ANDA #077083		 SUPPL-8 LEFLUNOMIDE BARR Labeling Approval
06/02/2026 LEFLUNOMIDE
ANDA #077083		 SUPPL-9 LEFLUNOMIDE BARR Labeling Approval
06/02/2026 ARSENIC TRIOXIDE
ANDA #206228		 SUPPL-13 ARSENIC TRIOXIDE ZYDUS PHARMS Labeling Approval
06/02/2026 SAXENDA
NDA #206321		 SUPPL-24 LIRAGLUTIDE NOVO Labeling Approval
06/02/2026 TIOCYSTIN
NDA #212927		 ORIG-1 TIOPRONIN CASPER PHARMA LLC Type 5 - New Formulation or New Manufacturer Approval
06/02/2026 ELUXADOLINE
ANDA #213511		 ORIG-1 ELUXADOLINE AUROBINDO PHARMA Approval
06/02/2026 OXCARBAZEPINE
ANDA #215332		 SUPPL-6 OXCARBAZEPINE AUCTA Labeling Approval
06/02/2026 ROMIDEPSIN
ANDA #219099		 ORIG-1 ROMIDEPSIN AMNEAL Approval
06/02/2026 RANLUSPEC
BLA #761480		 ORIG-1 RANIBIZUMAB-HKDZ LUPIN LIMITED Approval
06/03/2026 SERTRALINE HYDROCHLORIDE
ANDA #077345		 SUPPL-14 SERTRALINE HYDROCHLORIDE HERITAGE PHARMA AVET Labeling Approval
06/03/2026 ARGATROBAN IN DEXTROSE
NDA #201743		 SUPPL-3 ARGATROBAN SANDOZ Labeling Approval
06/03/2026 FARXIGA
NDA #202293		 SUPPL-35 DAPAGLIFLOZIN ASTRAZENECA AB Labeling Approval
06/03/2026 INVOKANA
NDA #204042		 SUPPL-44 CANAGLIFLOZIN JANSSEN PHARMS Labeling Approval
06/03/2026 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA #204196		 ORIG-1 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE SUN PHARM Approval
06/03/2026 AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
ANDA #208111		 SUPPL-11 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE PADAGIS ISRAEL Labeling Approval
06/03/2026 QTERN
NDA #209091		 SUPPL-9 DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Labeling Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #209633		 ORIG-1 TOFACITINIB CITRATE BRECKENRIDGE Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #209738		 ORIG-2 TOFACITINIB CITRATE MICRO LABS Approval
06/03/2026 STEGLATRO
NDA #209803		 SUPPL-12 ERTUGLIFLOZIN MSD SUB MERCK Labeling Approval
06/03/2026 STEGLUJAN
NDA #209805		 SUPPL-22 ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE MSD SUB MERCK Labeling Approval
06/03/2026 VASOPRESSIN
ANDA #213988		 SUPPL-2 VASOPRESSIN DR REDDYS Manufacturing (CMC) Approval
06/03/2026 VASOPRESSIN
ANDA #213988		 SUPPL-3 VASOPRESSIN DR REDDYS Manufacturing (CMC) Approval
06/03/2026 VASOPRESSIN IN DEXTROSE 5%
ANDA #213988		 SUPPL-2 VASOPRESSIN DR REDDYS Manufacturing (CMC) Approval
06/03/2026 VASOPRESSIN IN DEXTROSE 5%
ANDA #213988		 SUPPL-3 VASOPRESSIN DR REDDYS Manufacturing (CMC) Approval
06/03/2026 BRENZAVVY
NDA #214373		 SUPPL-2 BEXAGLIFLOZIN THERACOSBIO Labeling Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #215356		 ORIG-1 TOFACITINIB CITRATE AUROBINDO PHARMA LTD Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #217298		 ORIG-1 TOFACITINIB CITRATE MSN Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #217299		 ORIG-1 TOFACITINIB CITRATE MSN Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #218096		 ORIG-1 TOFACITINIB CITRATE APOTEX Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #218407		 ORIG-1 TOFACITINIB CITRATE SUN PHARM INDS INC Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #219395		 ORIG-1 TOFACITINIB CITRATE SPECGX LLC Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #219530		 ORIG-1 TOFACITINIB CITRATE MACLEODS PHARMS LTD Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #220137		 ORIG-1 TOFACITINIB CITRATE SOMERSET THERAPS LLC Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #220458		 ORIG-1 TOFACITINIB CITRATE APOTEX Approval
06/03/2026 TOFACITINIB CITRATE
ANDA #220458		 ORIG-2 TOFACITINIB CITRATE APOTEX Tentative Approval
06/04/2026 CHILDREN'S ALLEGRA ALLERGY
NDA #021909		 SUPPL-19 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
06/04/2026 CHILDREN'S ALLEGRA HIVES
NDA #021909		 SUPPL-19 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Labeling Approval
06/04/2026 DIPYRIDAMOLE
ANDA #074521		 SUPPL-25 DIPYRIDAMOLE HIKMA Manufacturing (CMC) Approval
06/04/2026 CANGRELOR
ANDA #213703		 ORIG-1 CANGRELOR MSN Approval
06/04/2026 HALOPERIDOL
ANDA #214470		 ORIG-1 HALOPERIDOL ALEMBIC Approval
06/04/2026 RAMELTEON
ANDA #215243		 SUPPL-4 RAMELTEON MICRO LABS Manufacturing (CMC) Approval
06/04/2026 RAMELTEON
ANDA #215485		 ORIG-1 RAMELTEON HIBROW HLTHCARE Approval
06/04/2026 DALBAVANCIN HYDROCHLORIDE
ANDA #219604		 ORIG-1 DALBAVANCIN HYDROCHLORIDE BE PHARMS Approval
06/05/2026 LIDOCAINE HYDROCHLORIDE
ANDA #040078		 SUPPL-38 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
06/05/2026 ACYCLOVIR
ANDA #075211		 SUPPL-16 ACYCLOVIR AUROBINDO PHARMA USA Labeling Approval
06/05/2026 ACETAZOLAMIDE SODIUM
ANDA #202693		 SUPPL-12 ACETAZOLAMIDE SODIUM AVET LIFESCIENCES Labeling Approval
06/05/2026 RABEPRAZOLE SODIUM
ANDA #204237		 SUPPL-18 RABEPRAZOLE SODIUM RUBICON RESEARCH Labeling Approval
06/05/2026 SOTALOL HYDROCHLORIDE
ANDA #207429		 SUPPL-8 SOTALOL HYDROCHLORIDE REGCON HOLDINGS Labeling Approval
06/05/2026 DABIGATRAN ETEXILATE MESYLATE
ANDA #207961		 SUPPL-13 DABIGATRAN ETEXILATE MESYLATE HETERO LABS LTD III Labeling Approval
06/05/2026 ABIRATERONE ACETATE
ANDA #208371		 SUPPL-5 ABIRATERONE ACETATE RISING Labeling Approval
06/05/2026 TOFACITINIB CITRATE
ANDA #209829		 ORIG-2 TOFACITINIB CITRATE ZYDUS PHARMS Approval
06/05/2026 EPIDIOLEX
NDA #210365		 SUPPL-24 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
06/05/2026 EPIDIOLEX
NDA #210365		 SUPPL-29 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
06/05/2026 EPIDIOLEX
NDA #210365		 SUPPL-30 CANNABIDIOL JAZZ PHARMS RES Labeling Approval
06/05/2026 BRIMONIDINE TARTRATE
ANDA #216772		 SUPPL-2 BRIMONIDINE TARTRATE UPSHER SMITH LABS Labeling Approval
06/05/2026 EMGALITY
BLA #761063		 SUPPL-13 GALCANEZUMAB-GNLM ELI LILLY AND CO Approval
06/05/2026 AJOVY
BLA #761089		 SUPPL-36 FREMANEZUMAB-VFRM TEVA PHARMS USA Approval
06/05/2026 VYEPTI
BLA #761119		 SUPPL-15 EPTINEZUMAB-JJMR Lundbeck Seattle BioPharmaceuticals, Inc. Approval
06/05/2026 IMULDOSA
BLA #761364		 SUPPL-5 USTEKINUMAB-SRLF ACCORD BIOPHARMA INC. Approval
06/05/2026 HYMPAVZI
BLA #761369		 SUPPL-3 MARSTACIMAB-HNCQ PFIZER INC Approval
06/06/2026 PROVOCHOLINE
NDA #019193		 SUPPL-32 METHACHOLINE CHLORIDE METHAPHARM Labeling Approval
06/08/2026 ESTRADIOL
ANDA #075182		 SUPPL-30 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
06/08/2026 ESTRADIOL
ANDA #075182		 SUPPL-34 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
06/08/2026 ESTRADIOL
ANDA #075182		 SUPPL-38 ESTRADIOL MYLAN TECHNOLOGIES Labeling Approval
06/08/2026 ALENDRONATE SODIUM
ANDA #076584		 SUPPL-18 ALENDRONATE SODIUM RISING Labeling Approval
06/08/2026 RISEDRONATE SODIUM
ANDA #077132		 SUPPL-13 RISEDRONATE SODIUM TEVA PHARMS USA Labeling Approval
06/08/2026 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-15 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
06/08/2026 RISPERIDONE
ANDA #077494		 SUPPL-27 RISPERIDONE PH HEALTH Labeling Approval
06/08/2026 OXCARBAZEPINE
ANDA #078005		 SUPPL-12 OXCARBAZEPINE ANI PHARMS Labeling Approval
06/08/2026 OXCARBAZEPINE
ANDA #078005		 SUPPL-15 OXCARBAZEPINE ANI PHARMS Labeling Approval
06/08/2026 LOSARTAN POTASSIUM
ANDA #078232		 SUPPL-44 LOSARTAN POTASSIUM LUPIN LTD Labeling Approval
06/08/2026 LOSARTAN POTASSIUM
ANDA #090382		 SUPPL-38 LOSARTAN POTASSIUM STRIDES PHARMA Labeling Approval
06/08/2026 RISEDRONATE SODIUM
ANDA #200296		 SUPPL-8 RISEDRONATE SODIUM AUROBINDO PHARMA LTD Labeling Approval
06/08/2026 LEVETIRACETAM
ANDA #204754		 SUPPL-1 LEVETIRACETAM AIPING PHARM INC Labeling Approval
06/08/2026 LEVETIRACETAM
ANDA #204754		 SUPPL-3 LEVETIRACETAM AIPING PHARM INC Labeling Approval
06/08/2026 ATOVAQUONE
ANDA #209685		 SUPPL-10 ATOVAQUONE GLENMARK SPECLT Labeling Approval
06/08/2026 ATOVAQUONE
ANDA #210692		 SUPPL-6 ATOVAQUONE HETERO LABS LTD III Labeling Approval
06/08/2026 MACITENTAN
ANDA #211000		 ORIG-1 MACITENTAN AMNEAL Approval
06/08/2026 MACITENTAN
ANDA #211187		 ORIG-1 MACITENTAN TEVA PHARMS USA INC Approval
06/08/2026 LABETALOL HYDROCHLORIDE
ANDA #212990		 SUPPL-2 LABETALOL HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
06/08/2026 GALLIUM GA 68 GOZETOTIDE
ANDA #216410		 ORIG-1 GALLIUM GA-68 GOZETOTIDE RADIOMEDIX Approval
06/08/2026 SUCCINYLCHOLINE CHLORIDE
ANDA #217873		 SUPPL-3 SUCCINYLCHOLINE CHLORIDE STERISCIENCE Labeling Approval
06/08/2026 GADOBUTROL
ANDA #219146		 ORIG-1 GADOBUTROL ZENARA Approval
06/08/2026 OPDUALAG
BLA #761234		 SUPPL-11 NIVOLUMAB;RELATLIMAB-RMBW BRISTOL MYERS SQUIBB Approval
06/09/2026 ZYVOX
NDA #021130		 SUPPL-50 LINEZOLID PFIZER Labeling Approval
06/09/2026 ZYVOX
NDA #021131		 SUPPL-48 LINEZOLID PFIZER Labeling Approval
06/09/2026 ZYVOX
NDA #021132		 SUPPL-50 LINEZOLID PFIZER Labeling Approval
06/09/2026 VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #050671		 SUPPL-43 VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-2 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-6 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-10 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-11 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-12 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 CAPECITABINE
ANDA #202593		 SUPPL-17 CAPECITABINE ACCORD HLTHCARE Labeling Approval
06/09/2026 AZACITIDINE
ANDA #204949		 SUPPL-4 AZACITIDINE PHARMOBEDIENT Labeling Approval
06/09/2026 AZACITIDINE
ANDA #204949		 SUPPL-6 AZACITIDINE PHARMOBEDIENT Labeling Approval
06/09/2026 AZACITIDINE
ANDA #204949		 SUPPL-7 AZACITIDINE PHARMOBEDIENT Labeling Approval
06/09/2026 LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #206473		 SUPPL-13 LINEZOLID HOSPIRA Labeling Approval
06/09/2026 CEPHALEXIN
ANDA #213568		 ORIG-1 CEPHALEXIN AUROBINDO PHARMA Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #215552		 ORIG-1 TOFACITINIB CITRATE YAOPHARMA CO LTD Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #218821		 ORIG-1 TOFACITINIB CITRATE CONCORD BIOTECH LTD Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #218900		 ORIG-1 TOFACITINIB CITRATE SAPTALIS PHARMS Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #219370		 ORIG-1 TOFACITINIB CITRATE AUSON Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #219830		 ORIG-1 TOFACITINIB CITRATE ORIENT PHARMA Approval
06/09/2026 TOFACITINIB CITRATE
ANDA #219830		 ORIG-2 TOFACITINIB CITRATE ORIENT PHARMA Tentative Approval
06/09/2026 EBGLYSS
BLA #761306		 SUPPL-6 LEBRIKIZUMAB-LBKZ ELI LILLY AND CO Approval
06/10/2026 MALARONE
NDA #021078		 SUPPL-26 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
06/10/2026 MALARONE PEDIATRIC
NDA #021078		 SUPPL-26 ATOVAQUONE; PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
06/10/2026 FLUORESCITE
NDA #021980		 SUPPL-12 FLUORESCEIN SODIUM ALCON LABS INC Labeling Approval
06/10/2026 TERLIVAZ
NDA #022231		 SUPPL-4 TERLIPRESSIN ACETATE MALLINCKRODT IRELAND Labeling Approval
06/10/2026 ARGATROBAN IN SODIUM CHLORIDE
NDA #022434		 SUPPL-14 ARGATROBAN CIPLA Labeling Approval
06/10/2026 CLINDAMYCIN PHOSPHATE
ANDA #064050		 SUPPL-28 CLINDAMYCIN PHOSPHATE PADAGIS US Labeling Approval
06/10/2026 VALACYCLOVIR HYDROCHLORIDE
ANDA #203047		 SUPPL-20 VALACYCLOVIR HYDROCHLORIDE HETERO LABS LTD V Labeling Approval
06/10/2026 DORZOLAMIDE HYDROCHLORIDE
ANDA #205294		 SUPPL-8 DORZOLAMIDE HYDROCHLORIDE FDC LTD Labeling Approval
06/10/2026 DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
ANDA #207825		 SUPPL-1 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE PHARMOBEDIENT Labeling Approval
06/10/2026 ARGATROBAN IN SODIUM CHLORIDE
NDA #209552		 SUPPL-8 ARGATROBAN EUGIA PHARMA SPECLTS Labeling Approval
06/10/2026 FOSAPREPITANT DIMEGLUMINE
ANDA #212143		 SUPPL-4 FOSAPREPITANT DIMEGLUMINE CHIA TAI TIANQING Labeling Approval
06/10/2026 VORANIGO
NDA #218784		 SUPPL-4 VORASIDENIB SERVIER Labeling Approval
06/10/2026 PROPRANOLOL HYDROCHLORIDE
ANDA #219165		 ORIG-1 PROPRANOLOL HYDROCHLORIDE PAI HOLDINGS Approval
06/10/2026 EXDENSUR
BLA #761458		 SUPPL-2 DEPEMOKIMAB-ULAA GLAXOSMITHKLINE LLC Approval
Back to Top