›May 25, 2023approval1175d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›May 26, 2023approval1174d agoMEKINIST (TRAMETINIB DIMETHYL SULFOXIDE) — FDA approvalSpexotras

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Spexotras →fda approvals ↗

›May 26, 2023approval1174d agoTAFINLAR (DABRAFENIB MESYLATE) — FDA approvaldabrafenib mesylate ODT

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →dabrafenib mesylate ODT →fda approvals ↗

›May 26, 2023approval1174d agoTEZSPIRE (TEZEPELUMAB-EKKO) — FDA approvaltezepelumab

Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS

full page →tezepelumab →fda approvals ↗

1168d ago

ARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗

›Jun 1, 2023approval1168d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

›Jun 2, 2023approval1167d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Jun 2, 2023approval1167d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Jun 2, 2023approval1167d agoADBRY (TRALOKINUMAB) — FDA approvaltralokinumab

Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION

full page →tralokinumab →fda approvals ↗

1164d ago

QUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

›Jun 5, 2023approval1164d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

›Jun 5, 2023approval1164d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

›Jun 5, 2023approval1164d agoQUETIAPINE FUMARATE — FDA approvalquetiapine fumarate ER

Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL

full page →quetiapine fumarate ER →fda approvals ↗

›Jun 5, 2023approval1164d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Jun 5, 2023approval1164d agoORILISSA (ELAGOLIX SODIUM) — FDA approvalelagolix sodium

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →elagolix sodium →fda approvals ↗

›Jun 5, 2023approval1164d agoORIAHNN (COPACKAGED) (ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE) — FDA approvalORIAHNN (COPACKAGED)

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →ORIAHNN (COPACKAGED) →fda approvals ↗

›Jun 6, 2023approval1163d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

›Jun 6, 2023approval1163d agoTRACLEER (BOSENTAN) — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

Sponsor: ACTELION. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 6, 2023approval1163d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 7, 2023approval1162d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

›Jun 7, 2023approval1162d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

Sponsor: GRAVITI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 7, 2023approval1162d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗

›Jun 7, 2023approval1162d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

›Jun 7, 2023approval1162d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

›Jun 7, 2023approval1162d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

›Jun 7, 2023approval1162d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

›Jun 7, 2023approval1162d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Jun 7, 2023approval1162d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗

›Jun 7, 2023approval1162d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

›Jun 7, 2023approval1162d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗

›Jun 8, 2023approval1161d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: UNICHEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 8, 2023approval1161d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: UNICHEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

›Jun 8, 2023approval1161d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc