Last Updated: June 13, 2026

Generic Companies with Tentative Approvals for: sertraline hydrochloride

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sertraline hydrochloride 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
Mylan Pharms Inc	sertraline hydrochloride	076540	EQ 50MG BASE	TABLET;ORAL
Mylan Pharms Inc	sertraline hydrochloride	076540	EQ 100MG BASE	TABLET;ORAL
Ranbaxy Labs Ltd	sertraline hydrochloride	078053	EQ 20MG BASE/ML	CONCENTRATE;ORAL
Mylan Pharms Inc	sertraline hydrochloride	076540	EQ 25MG BASE	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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