Last Updated: August 12, 2026

Generic Companies with Tentative Approvals for: amantadine

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amantadine 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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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Zydus	amantadine hydrochloride	214897	EQ 68.5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL
Zydus	amantadine	214897	137MG	CAPSULE, EXTENDED RELEASE;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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