Calendar

Week of Jan 12, 2026

Jan 14, 2026approval212d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 14, 2026approval212d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

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

full page →fda approvals ↗

Jan 14, 2026approval212d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

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Jan 14, 2026approval212d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval212d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval212d agoROGAINE (FOR WOMEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval212d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval212d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

Jan 14, 2026approval212d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗

Jan 14, 2026approval212d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

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

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval212d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval212d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

Jan 14, 2026approval212d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval212d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: SOMERSET THERAPS LLC. Form: TABLET

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval212d agoELTROMBOPAG OLAMINE — FDA approvalZydus Therapeutics Inc

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

full page →fda approvals ↗

Jan 14, 2026approval212d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 14, 2026approval212d agoTOREMIFENE CITRATE — FDA approvalTOREMIFENE CITRATE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →TOREMIFENE CITRATE →fda approvals ↗

Jan 14, 2026approval212d agoMYCOPHENOLATE SODIUM — FDA approvalmycophenolate sodium DR

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →mycophenolate sodium DR →fda approvals ↗

Jan 14, 2026approval212d agoROGAINE EXTRA STRENGTH (FOR MEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval212d agoSITAGLIPTIN PHOSPHATE — FDA approvalSITAGLIPTIN PHOSPHATE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →SITAGLIPTIN PHOSPHATE →fda approvals ↗

Jan 14, 2026approval212d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Jan 14, 2026approval212d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval212d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval212d agoANAGRELIDE HYDROCHLORIDE — FDA approvalANAGRELIDE HYDROCHLORIDE

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →ANAGRELIDE HYDROCHLORIDE →fda approvals ↗

Jan 14, 2026recall212d agoMedinatura New Mexico, inc. recall (Cls I)

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoSpecGx, LLC recall (Cls II)SpecGx LLC

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoImprimis NJOF, LLC recall (Cls II)Fosun Pharma USA Inc

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoMedinatura New Mexico, inc. recall (Cls I)

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoSignature Formulations, LLC recall (Cls II)

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoSpecGx, LLC recall (Cls II)SpecGx LLC

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoSignature Formulations, LLC recall (Cls II)

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoAvKARE recall (Cls II)AvKare LLC

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing

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Jan 14, 2026recall212d agoAlembic Pharmaceuticals Limited recall (Cls III)Alembic Pharmaceuticals Inc

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoImprimis NJOF, LLC recall (Cls II)OCULAR THERAPEUTIX, INC

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall212d agoImprimis NJOF, LLC recall (Cls II)OCULAR THERAPEUTIX, INC

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1 — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

full page →fda recalls ↗

Jan 15, 2026approval211d agoOSELTAMIVIR PHOSPHATE — FDA approvalOSELTAMIVIR PHOSPHATE

Sponsor: AJANTA PHARMA LTD. Form: FOR SUSPENSION. Route: ORAL

full page →OSELTAMIVIR PHOSPHATE →fda approvals ↗

Jan 15, 2026approval211d agoREZUROCK (BELUMOSUDIL MESYLATE) — FDA approvalbelumosudil mesylate

Sponsor: KADMON PHARMS LLC. Form: TABLET. Route: ORAL

full page →belumosudil mesylate →fda approvals ↗