Calendar

pharmadog

Week of Feb 2, 2026

Feb 3, 2026approval208d agoPREGABALIN — FDA approvalPREGABALIN

Sponsor: MSN. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →PREGABALIN →fda approvals ↗

Feb 3, 2026approval208d agoSELENIOUS ACID — FDA approvalRK Pharma Inc

Sponsor: KINDOS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 3, 2026approval208d agoVYKOURA (LEUCOVORIN CALCIUM) — FDA approvalLEUCOVORIN CALCIUM

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

full page →LEUCOVORIN CALCIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoDYNA-HEX 2 (CHLORHEXIDINE GLUCONATE) — FDA approvalCoorg Instituite of Dental Sciences

Sponsor: XTTRIUM. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Feb 3, 2026approval208d agoALENDRONATE SODIUM — FDA approvalALENDRONATE SODIUM

Sponsor: NOVITIUM PHARMA. Form: SOLUTION. Route: ORAL

full page →ALENDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

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

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: SUN PHARM INDUSTRIES. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: DR REDDYS LABS LTD. Form: TABLET. Route: ORAL

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

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

full page →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 3, 2026approval208d agoBINOSTO (ALENDRONATE SODIUM) — FDA approvalOrganon & Co.

Sponsor: RADIUS. Form: TABLET, EFFERVESCENT. Route: ORAL

full page →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalIBANDRONATE SODIUM

Sponsor: APOTEX. Form: INJECTABLE. Route: INTRAVENOUS

full page →IBANDRONATE SODIUM →fda approvals ↗

Feb 3, 2026approval208d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

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

full page →fda approvals ↗

Feb 3, 2026approval208d agoDOXORUBICIN HYDROCHLORIDE — FDA approvalBAXTER INTERNATIONAL INC

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE, LIPOSOMAL. Route: INJECTION

full page →fda approvals ↗

Feb 3, 2026approval208d agoACTONEL (RISEDRONATE SODIUM) — FDA approvalAllergan Finance LLC

Sponsor: APIL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 3, 2026approval208d agoFOSAMAX PLUS D (ALENDRONATE SODIUM) — FDA approval(alendronate sodium + cholecalciferol)

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

full page →(alendronate sodium + cholecalciferol) →fda approvals ↗

Feb 3, 2026approval208d agoIBANDRONATE SODIUM — FDA approvalDR REDDYS LABORATORIES LTD

Sponsor: NANG KUANG PHARM CO. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 4, 2026approval207d agoATROPINE SULFATE — FDA approvalATROPINE SULFATE

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →ATROPINE SULFATE →fda approvals ↗

Feb 4, 2026approval207d agoCARBOPLATIN — FDA approvalOncotelic Therapeutics, Inc.

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INTRAVENOUS

full page →fda approvals ↗

Feb 4, 2026recall207d agoHaleon US Holdings LLC recall (Cls III)

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall207d agoBaxter Healthcare Corporation recall (Cls II)Baxter Healthcare Corp

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall207d agoNOVADOZ PHARMACEUTICALS LLC recall (Cls III)Novadoz Pharmaceuticals LLC

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall207d agoGreenstone Llc recall (Cls II)Greenstone LLC

methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing

full page →fda recalls ↗

Feb 4, 2026recall207d agoSato Pharmaceutical Co., Ltd recall (Cls II)TAKEDA PHARMACEUTICAL CO LTD

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing

full page →fda recalls ↗

Feb 5, 2026approval206d agoAZTREONAM — FDA approvalAZTREONAM

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →AZTREONAM →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 5, 2026approval206d agoNICOTINE POLACRILEX — FDA approvalPL Developments Copiague LLC

Sponsor: P AND L. Form: GUM, CHEWING. Route: BUCCAL

full page →fda approvals ↗

Feb 5, 2026approval206d agoNYSTATIN — FDA approvalActavis Mid Atlantic LLC

Sponsor: STERANCO HLTHCARE. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 5, 2026approval206d agoBUMETANIDE — FDA approvalBUMETANIDE

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →BUMETANIDE →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

Sponsor: EUGIA PHARMA SPECLTS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 5, 2026approval206d agoPRUCALOPRIDE SUCCINATE — FDA approvalSpecGx LLC

Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Feb 5, 2026approval206d agoCARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA) — FDA approvalcarbidopa

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →carbidopa →fda approvals ↗

Feb 5, 2026approval206d agoMYQORZO (AFICAMTEN) — FDA approvalaficamten

Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL

full page →aficamten →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Feb 5, 2026approval206d agoHYDROCORTISONE SODIUM SUCCINATE — FDA approvalHYDROCORTISONE SODIUM SUCCINATE

Sponsor: APOTEX. Form: INJECTABLE. Route: INJECTION

full page →HYDROCORTISONE SODIUM SUCCINATE →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

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

full page →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalEfudex

Sponsor: ALEMBIC. Form: INJECTABLE. Route: INJECTION

full page →Efudex →fda approvals ↗

Feb 5, 2026approval206d agoFLUOROURACIL — FDA approvalExtrovis AG

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

full page →fda approvals ↗

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Week of Feb 2, 2026