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Jan 7, 2026approval216d agoNORGESTIMATE AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL-28

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

Jan 7, 2026approval216d agoLEVOCETIRIZINE DIHYDROCHLORIDE — FDA approvalLEVOCETIRIZINE DIHYDROCHLORIDE

Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL

full page →LEVOCETIRIZINE DIHYDROCHLORIDE →fda approvals ↗

Jan 7, 2026approval216d agoMETOLAZONE — FDA approvalMETOLAZONE

Sponsor: INNOGENIX. Form: TABLET. Route: ORAL

full page →METOLAZONE →fda approvals ↗

Jan 7, 2026recall216d agoZydus Pharmaceuticals (USA) Inc recall (Cls III)LB PHARMACEUTICALS INC

traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. — Status: Ongoing

full page →fda recalls ↗

Jan 7, 2026recall216d agoGlenmark Pharmaceuticals Inc., USA recall (Cls II)LB PHARMACEUTICALS INC

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 — Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. — Status: Ongoing

full page →fda recalls ↗

Jan 7, 2026recall216d agoNovo Nordisk Inc. recall (Cls II)NOVO NORDISK A S

Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing

full page →fda recalls ↗

Jan 7, 2026recall216d agoNovo Nordisk Inc. recall (Cls II)NOVO NORDISK A S

Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14 — Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe — Status: Ongoing

full page →fda recalls ↗

Jan 7, 2026recall216d agoCareFusion 213, LLC recall (Cls II)Coorg Instituite of Dental Sciences

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29 — Reason: Lack of Assurance of Sterlity — Status: Ongoing

full page →fda recalls ↗

Jan 8, 2026approval215d agoENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approvalensartinib hydrochloride

Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL

full page →ensartinib hydrochloride →fda approvals ↗

Jan 8, 2026approval215d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval215d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval215d agoACETAZOLAMIDE — FDA approvalACETAZOLAMIDE

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

full page →ACETAZOLAMIDE →fda approvals ↗

Jan 8, 2026approval215d agoSAPROPTERIN DIHYDROCHLORIDE — FDA approvalSAPROPTERIN DIHYDROCHLORIDE

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

full page →SAPROPTERIN DIHYDROCHLORIDE →fda approvals ↗

Jan 8, 2026approval215d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Jan 8, 2026approval215d agoMAGNESIUM SULFATE — FDA approvalMAGNESIUM SULFATE

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

full page →MAGNESIUM SULFATE →fda approvals ↗

Jan 8, 2026approval215d agoFLUCONAZOLE — FDA approvalDiflucan

Sponsor: FDC LTD. Form: TABLET. Route: ORAL

full page →Diflucan →fda approvals ↗

Jan 8, 2026approval215d agoFUROSEMIDE — FDA approvalFurosemide Sun

Sponsor: MICRO LABS. Form: INJECTABLE. Route: INJECTION

full page →Furosemide Sun →fda approvals ↗

Jan 8, 2026approval215d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Jan 9, 2026approval214d agoNARCAN (NALOXONE HYDROCHLORIDE) — FDA approvalEmergent Devices Inc

Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Jan 9, 2026approval214d agoMETHYLPHENIDATE HYDROCHLORIDE — FDA approvalMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: ABHAI LLC. Form: SOLUTION. Route: ORAL

full page →METHYLPHENIDATE HYDROCHLORIDE →fda approvals ↗

Jan 9, 2026approval214d agoAMITRIPTYLINE HYDROCHLORIDE — FDA approvalAlgoTherapeutix SAS

Sponsor: UNIQUE PHARM. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 9, 2026approval214d agoVARENICLINE TARTRATE — FDA approvalMylan Pharmaceuticals Inc

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 9, 2026approval214d agoEVEROLIMUS — FDA approvalEVEROLIMUS

Sponsor: BIOCON PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →EVEROLIMUS →fda approvals ↗

Jan 9, 2026approval214d agoNEXLETOL (BEMPEDOIC ACID) — FDA approvalbempedoic acid

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →bempedoic acid →fda approvals ↗

Jan 9, 2026approval214d agoNEXLIZET (BEMPEDOIC ACID) — FDA approval(bempedoic acid + ezetimibe)

Sponsor: ESPERION THERAPS INC. Form: TABLET. Route: ORAL

full page →(bempedoic acid + ezetimibe) →fda approvals ↗

Jan 9, 2026approval214d agoPHYTONADIONE — FDA approvalSigyn Therapeutics, Inc.

Sponsor: SUNNY. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Jan 12, 2026

Jan 12, 2026approval211d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Jan 12, 2026approval

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