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Week of Feb 16, 2026

50

Feb 17, 2026approval182d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Feb 17, 2026approval182d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

Feb 17, 2026approval182d agoIDELALISIB — FDA approvalIDELALISIB

Sponsor: NATCO. Form: TABLET. Route: ORAL

full page →IDELALISIB →fda approvals ↗

Feb 17, 2026approval182d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Feb 17, 2026approval182d agoTELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Feb 17, 2026approval182d agoTELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Feb 17, 2026approval182d agoTELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Feb 17, 2026approval182d agoTELMISARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Feb 17, 2026approval182d agoSODIUM PHENYLBUTYRATE — FDA approvalSODIUM PHENYLBUTYRATE

Sponsor: NAVINTA LLC. Form: TABLET. Route: ORAL

full page →SODIUM PHENYLBUTYRATE →fda approvals ↗

Feb 17, 2026approval182d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: TAGI. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Feb 17, 2026approval182d agoCOLCHICINE — FDA approvalCOLCHICINE

Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL

full page →COLCHICINE →fda approvals ↗

Feb 17, 2026approval182d agoAMBRISENTAN — FDA approvalAMBRISENTAN

Sponsor: SIGMAPHARM LABS LLC. Form: TABLET. Route: ORAL

full page →AMBRISENTAN →fda approvals ↗

Feb 17, 2026approval182d agoMEDICAL AIR, USP — FDA approval

Sponsor: INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC. Form: GAS. Route: INHALATION

full page →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoAMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: ACS DOBFAR. Form: INJECTABLE. Route: INJECTION

full page →UNASYN →fda approvals ↗

Feb 17, 2026approval182d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Feb 17, 2026approval182d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗

Feb 17, 2026approval182d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL

full page →METRONIDAZOLE →fda approvals ↗

Feb 17, 2026approval182d agoMETRONIDAZOLE — FDA approvalMETRONIDAZOLE

Sponsor: ALEMBIC. Form: GEL. Route: TOPICAL

full page →METRONIDAZOLE →fda approvals ↗

Feb 17, 2026approval182d agoRELGAABI (GABAPENTIN) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 17, 2026approval182d agoANAGRELIDE HYDROCHLORIDE — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 17, 2026approval182d agoAMLODIPINE BESYLATE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Feb 17, 2026approval182d agoMEROPENEM — FDA approvalMEROPENEM

Sponsor: QILU. Form: INJECTABLE. Route: INJECTION

full page →MEROPENEM →fda approvals ↗

Feb 18, 2026approval181d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Feb 18, 2026approval181d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Feb 18, 2026approval181d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Feb 18, 2026approval181d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Feb 18, 2026approval181d agoTOFACITINIB CITRATE — FDA approvaltofacitinib citrate ER

Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL

full page →tofacitinib citrate ER →fda approvals ↗

Feb 18, 2026approval181d agoARBLI (LOSARTAN POTASSIUM) — FDA approvalLOSARTAN POTASSIUM

Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Feb 18, 2026approval181d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalEzra Ventures LLC

Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 18, 2026approval181d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalEzra Ventures LLC

Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 18, 2026approval181d agoARIPIPRAZOLE — FDA approvalaripiprazole LA

Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →aripiprazole LA →fda approvals ↗

Feb 18, 2026approval181d agoEBANGA (ANSUVIMAB-ZYKL) — FDA approvalansuvimab

Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)

full page →ansuvimab →fda approvals ↗

Feb 18, 2026approval181d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: IPCA LABS LTD. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Feb 19, 2026approval180d agoELREXFIO (ELRANATAMAB) — FDA approvalelranatamab

Sponsor: PFIZER INC. Form: SOLUTION. Route: INJECTION

full page →elranatamab →fda approvals ↗

Feb 19, 2026approval180d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: AVET LIFESCIENCES. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 19, 2026approval180d agoBRIVARACETAM — FDA approvalBRIVARACETAM

Sponsor: MSN. Form: SOLUTION. Route: ORAL

full page →BRIVARACETAM →fda approvals ↗

Feb 19, 2026approval180d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗

Feb 19, 2026approval180d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 19, 2026approval180d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 19, 2026approval180d agoVFEND (VORICONAZOLE) — FDA approvalGreenstone LLC

Sponsor: PF PRISM CV. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Feb 19, 2026approval180d agoCALQUENCE (ACALABRUTINIB MALEATE) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: TABLET. Route: ORAL

full page →CALQUENCE →fda approvals ↗

Feb 19, 2026approval180d agoCALQUENCE (ACALABRUTINIB) — FDA approvalCALQUENCE

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →CALQUENCE →fda approvals ↗

Feb 19, 2026approval180d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

Sponsor: ABBVIE. Form: TABLET. Route: ORAL

full page →venetoclax →fda approvals ↗

Feb 20, 2026approval179d agoFAVLYXA (FLUOROURACIL) — FDA approvalEfudex

Sponsor: AVYXA HOLDINGS. Form: SOLUTION. Route: INTRAVENOUS

full page →Efudex →fda approvals ↗

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