Last Updated: July 13, 2026

Generic Companies with Tentative Approvals for: Impax Labs

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Impax Labs 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
Impax Labs	venlafaxine hydrochloride	078057	37.5MG	CAPSULE, EXTENDED RELEASE; ORAL
Impax Labs Inc	duloxetine hydrochloride	090669	EQ 20MG BASE	CAPSULE, DELAYED RELEASE; ORAL
Impax Labs	oxycodone hydrochloride	076318	80MG	TABLET, EXTENDED RELEASE; ORAL
Impax Labs Inc	duloxetine hydrochloride	090669	EQ 30MG BASE	CAPSULE, DELAYED RELEASE; ORAL
Impax Labs	venlafaxine hydrochloride	078057	150MG	CAPSULE, EXTENDED RELEASE; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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