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Week of Feb 16, 2026

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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 18, 2026recall181d agoMcKesson recall (Cls I)MCKESSON CORP

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 — Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)Transdermal Delivery Solutions Corp

Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoPro Numb Tattoo Numbing Spray LLC recall (Cls II)Sustained Therapeutics Inc

Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 — Reason: cGMP deviations — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoFresenius Kabi Compounding, LLC recall (Cls II)Revalesio Corp

thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoFresenius Kabi Compounding, LLC recall (Cls II)Revalesio Corp

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoAmerisource Health Services LLC recall (Cls II)KVK-Tech Inc

Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11 — Reason: Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)Transdermal Delivery Solutions Corp

Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)Transdermal Delivery Solutions Corp

Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)PFIZER INC

ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoFresenius Kabi Compounding, LLC recall (Cls II)Revalesio Corp

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Feb 18, 2026recall181d agoF.H. INVESTMENTS, Inc. (dba Asteria Health) recall (Cls II)Transdermal Delivery Solutions Corp

Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing

full page →fda recalls ↗

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