Calendar

pharmadog

Week of Mar 2, 2026

Mar 4, 2026approval164d agoBAL (DIMERCAPROL) — FDA approvalAkorn Operating Company LLC (Inactive)

Sponsor: PROVEPHARM SAS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 4, 2026approval164d agoROCURONIUM BROMIDE — FDA approvalROCURONIUM BROMIDE

Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION

full page →ROCURONIUM BROMIDE →fda approvals ↗

Mar 4, 2026approval164d agoEMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE) — FDA approvalHetero USA Inc

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 4, 2026approval164d agoCALCITONIN-SALMON (CALCITONIN SALMON) — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 4, 2026approval164d agoDESIPRAMINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS CO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 4, 2026approval164d agoGLIPIZIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoSlate Run Pharmaceuticals recall (Cls III)Slate Run Pharmaceuticals LLC

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoAvKARE recall (Cls II)AvKare LLC

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoLEO PHARMA INC recall (Cls II)IGC Pharma, Inc.

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoAgebox recall (Cls II)Children’s Hospital of Chongqing Medical University

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoAgebox recall (Cls II)Children’s Hospital of Chongqing Medical University

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 — Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren — Status: Ongoing

full page →fda recalls ↗

Mar 4, 2026recall164d agoWizcure Pharmaa Private Limited recall (Cls II)

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, — Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. — Status: Ongoing

full page →fda recalls ↗

Mar 5, 2026approval163d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalPrinston Pharmaceutical Inc

Sponsor: TEVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval163d agoCHOLESTYRAMINE — FDA approvalCHOLESTYRAMINE

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

full page →CHOLESTYRAMINE →fda approvals ↗

Mar 5, 2026approval163d agoIBUPROFEN — FDA approvalMidol

Sponsor: RUBICON RESEARCH. Form: SUSPENSION. Route: ORAL

full page →Midol →fda approvals ↗

Mar 5, 2026approval163d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗

Mar 5, 2026approval163d agoTALVEY (TALQUETAMAB-TGVS) — FDA approvaltalquetamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →talquetamab →fda approvals ↗

Mar 5, 2026approval163d agoOLANZAPINE — FDA approvalTEVA PHARMACEUTICAL INDUSTRIES LTD

Sponsor: ANTHEA PHARMA. Form: POWDER. Route: INTRAMUSCULAR

full page →fda approvals ↗

Mar 5, 2026approval163d agoAPREPITANT — FDA approvalAPREPITANT

Sponsor: MYLAN. Form: EMULSION. Route: INTRAVENOUS

full page →APREPITANT →fda approvals ↗

Mar 5, 2026approval163d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval163d agoCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE) — FDA approvalAlgoTherapeutix SAS

Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL

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Mar 5, 2026approval163d agoXYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) — FDA approvalSanofi

Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL

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Mar 5, 2026approval163d agoKEFLEX (CEPHALEXIN) — FDA approvalBelcher Pharmaceuticals LLC

Sponsor: PRAGMA. Form: FOR SUSPENSION. Route: ORAL

full page →fda approvals ↗

Mar 5, 2026approval163d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

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

full page →ALDACTAZIDE →fda approvals ↗

Mar 5, 2026approval163d agoERLEADA (APALUTAMIDE) — FDA approvalapalutamide

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →apalutamide →fda approvals ↗

Mar 5, 2026approval163d agoPAROXETINE HYDROCHLORIDE — FDA approvalPAROXETINE HYDROCHLORIDE

Sponsor: ANNORA PHARMA. Form: SUSPENSION. Route: ORAL

full page →PAROXETINE HYDROCHLORIDE →fda approvals ↗

Mar 6, 2026approval162d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

full page →risankizumab →fda approvals ↗

Mar 6, 2026approval162d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INJECTION

full page →risankizumab →fda approvals ↗

Mar 6, 2026approval162d agoQUDEXY XR (TOPIRAMATE) — FDA approvalLP Pharmaceutical (Xiamen) Co Ltd

Sponsor: UPSHER SMITH LABS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 6, 2026approval162d agoPYLARIFY TRUVU (PIFLUFOLASTAT F-18) — FDA approval

Sponsor: APHELION. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Mar 6, 2026approval162d agoSANDIMMUNE (CYCLOSPORINE) — FDA approvalRestasis

Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL

full page →Restasis →fda approvals ↗

Mar 6, 2026approval162d agoQSYMIA (PHENTERMINE HYDROCHLORIDE) — FDA approval(phentermine hydrochloride + topiramate) ER

Sponsor: VIVUS LLC. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →(phentermine hydrochloride + topiramate) ER →fda approvals ↗

Mar 6, 2026approval162d agoTOPAMAX SPRINKLE (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Mar 6, 2026approval162d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

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

full page →tofacitinib citrate ER →fda approvals ↗

Mar 6, 2026approval162d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 6, 2026approval162d agoVITAMIN K1 (PHYTONADIONE) — FDA approvalPHYTONADIONE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PHYTONADIONE →fda approvals ↗

Mar 6, 2026approval162d agoVITAMIN K1 (PHYTONADIONE) — FDA approvalPHYTONADIONE

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →PHYTONADIONE →fda approvals ↗

Mar 6, 2026approval162d agoTOPAMAX (TOPIRAMATE) — FDA approvalJanssen Therapeutics

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

full page →fda approvals ↗

Mar 6, 2026approval162d agoSIPONIMOD — FDA approvalSIPONIMOD

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

full page →SIPONIMOD →fda approvals ↗

Mar 6, 2026approval162d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: APOTEX. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Mar 6, 2026approval162d agoSOTYKTU (DEUCRAVACITINIB) — FDA approvalBristol-Myers Squibb Co

Sponsor: BRISTOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 6, 2026approval162d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 6, 2026approval162d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

Mar 6, 2026approval162d agoGABAPENTIN — FDA approvalGABAPENTIN

Sponsor: PRINSTON INC. Form: CAPSULE. Route: ORAL

full page →GABAPENTIN →fda approvals ↗

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Week of Mar 2, 2026