Apotex — Drug & Asset Intelligence | Humanexa Signals

RegulatoryAugust 19, 2026

Apotex submits supplemental ANDA for Metformin Hydrochloride

Apotex has submitted a supplemental abbreviated new drug application (ANDA076706) for Metformin Hydrochloride, which is currently under standard review by the FDA. This submission adds a new competitor to the existing landscape of generic Metformin products, which are already widely available.

Sponsor company

Mechanism of action

Recent signals(33)

Apotex submits supplemental application for Metformin Hydrochloride

Apotex submits supplemental ANDA for Metformin Hydrochloride

FDA Accepts ANDA for Multiple Vitamins Injection by Apotex

FDA Accepts ANDA for Multiple Vitamins Injection by Apotex

FDA Submission Update for Brimonidine Tartrate by Apotex

Apotex submits supplemental application for Brimonidine Tartrate

FDA Accepts Supplement for Divalproex Sodium by Apotex

FDA Accepts Application for Everolimus by Apotex

FDA Submission Update for Ruxolitinib by Apotex

FDA accepts supplemental application for Alendronate Sodium by Apotex

FDA Accepts NDA for Trabectedin by Apotex

FDA Approves Sitagliptin and Metformin Hydrochloride Combination

Apotex submits supplemental application for Pomalidomide (ANDA 210164)

FDA Accepts Lenalidomide Supplement Application from Apotex

FDA Review Status for Pediatric Multiple Vitamins Injection by Apotex

FDA Review Status for Pediatric Multiple Vitamins Injection by Apotex

FDA Accepts Application for Canagliflozin by Apotex

Apotex submits ANDA for Tofacitinib Citrate, FDA review ongoing

Apotex submits supplemental ANDA for Carbidopa and Levodopa

FDA Accepts Supplement for Brimonidine Tartrate by Apotex

Apotex Submits ANDA for Brimonidine Tartrate

FDA Acceptance of Divalproex Sodium Supplement by Apotex

Apotex submits ANDA for Afatinib Dimaleate, FDA review in progress

FDA Submission Update for ANDA218552 by APOTEX

Apotex submits ANDA for Everolimus, FDA review in progress

FDA Accepts NDA for Trabectedin by Apotex

Apotex submits ANDA for Sitagliptin and Metformin Hydrochloride

Apotex submits ANDA for Azelastine Hydrochloride and Fluticasone Propionate

FDA Accepts ANDA for Posaconazole by Apotex

Apotex submits supplemental ANDA for Pomalidomide

FDA Accepts Supplement Application for Lenalidomide by Apotex

Apotex submits supplemental ANDA for Imiquimod

Apotex submits ANDA for Tofacitinib Citrate

Upcoming milestones

Related catalysts(15)

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Indications

Therapeutic areas

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