Calendar

pharmadog

Week of Dec 8, 2025

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

full page →OXYCODONE HYDROCHLORIDE →fda approvals ↗

Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalOXYCODONE HYDROCHLORIDE

Sponsor: HIKMA. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL

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Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

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Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

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Dec 9, 2025approval263d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

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Dec 9, 2025approval263d agoRYSTIGGO (ROZANOLIXIZUMAB-NOLI) — FDA approvalrozanolixizumab

Sponsor: UCB INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →rozanolixizumab →fda approvals ↗

Dec 9, 2025approval263d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoRECARBRIO (CILASTATIN SODIUM) — FDA approval(cilastatin sodium + imipenem + relebactam)

Sponsor: MSD MERCK CO. Form: POWDER. Route: INTRAVENOUS

full page →(cilastatin sodium + imipenem + relebactam) →fda approvals ↗

Dec 9, 2025approval263d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

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Dec 9, 2025approval263d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

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Dec 9, 2025approval263d agoIMITREX (SUMATRIPTAN) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Dec 9, 2025approval263d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

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

full page →DOXYCYCLINE HYCLATE →fda approvals ↗

Dec 9, 2025approval263d agoVECURONIUM BROMIDE — FDA approvalVECURONIUM BROMIDE

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

full page →VECURONIUM BROMIDE →fda approvals ↗

Dec 10, 2025approval262d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

Sponsor: IMMUNEX. Form: SYRINGE

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Dec 10, 2025approval262d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗

Dec 10, 2025approval262d agoMOMETASONE FUROATE — FDA approvalFougera Pharmaceuticals Inc

Sponsor: FOUGERA PHARMS. Form: OINTMENT. Route: TOPICAL

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Dec 10, 2025approval262d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗

Dec 10, 2025approval262d agoREZZAYO (REZAFUNGIN ACETATE) — FDA approvalrezafungin acetate

Sponsor: MUNDIPHARMA. Form: POWDER. Route: INTRAVENOUS

full page →rezafungin acetate →fda approvals ↗

Dec 10, 2025approval262d agoISOPROTERENOL HYDROCHLORIDE — FDA approvalISOPROTERENOL HYDROCHLORIDE

Sponsor: DEVA HOLDING AS. Form: INJECTABLE. Route: INJECTION

full page →ISOPROTERENOL HYDROCHLORIDE →fda approvals ↗

Dec 10, 2025approval262d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 10, 2025approval262d agoLOTEPREDNOL ETABONATE AND TOBRAMYCIN (LOTEPREDNOL ETABONATE) — FDA approvalloteprednol etabonate

Sponsor: ALEMBIC. Form: SUSPENSION/DROPS. Route: OPHTHALMIC

full page →loteprednol etabonate →fda approvals ↗

Dec 10, 2025approval262d agoTHALLOUS CHLORIDE TL 201 (THALLOUS CHLORIDE TL-201) — FDA approval

Sponsor: CURIUM. Form: INJECTABLE. Route: INJECTION

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Dec 10, 2025approval262d agoOMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE) — FDA approvalomeprazole DR

Sponsor: NOVITIUM PHARMA. Form: FOR SUSPENSION. Route: ORAL

full page →omeprazole DR →fda approvals ↗

Dec 10, 2025recall262d agoGlenmark Pharmaceuticals Inc., USA recall (Cls III)LB PHARMACEUTICALS INC

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. — Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoSafecor Health, LLC recall (Cls II)Mylan Institutional Inc

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B. — Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoPark Avenue Compounding recall (Cls II)Sawai Man Singh Medical College

Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1. — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 10, 2025recall262d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10. — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoBreckenridge Pharmaceutical, Inc. recall (Cls II)Breckenridge Pharmaceutical Inc

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10. — Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03. — Reason: cGMP deviations — Status: Ongoing

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Dec 10, 2025recall262d agoTeva Pharmaceuticals USA, Inc recall (Cls III)Terns Pharmaceuticals, Inc.

Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17. — Reason: Defective Container - A defect in the side-seal which allows leakage of product. — Status: Ongoing

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Dec 10, 2025recall262d agoBlossom Pharmaceuticals recall (Cls II)OB Pharmaceuticals

Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02. — Reason: cGMP deviations — Status: Ongoing

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Week of Dec 8, 2025