Last Updated: July 17, 2026

Generic Companies with Tentative Approvals for: Apotex

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Apotex Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Apotex	ponatinib hydrochloride	215893	EQ 15MG BASE	TABLET;ORAL
Apotex Inc	metformin hydrochloride, sitagliptin	214494	100MG	TABLET, EXTENDED RELEASE
Apotex Inc	levocetirizine dihydrochloride	211528	2.5MG/5ML	SOLUTION;ORAL
Apotex Inc	zoledronic acid	078533	EQ 4MG BASE/5ML	INJECTABLE; IV (INFUSION)
Apotex Inc	pregabalin	203022	25MG	CAPSULE;ORAL
Apotex Corp	sildenafil citrate	091378	25MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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