Last Updated: May 6, 2026

Done - Generic Drug Details

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Generic filers with tentative approvals for DONE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	10MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	5MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL

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

US Patents and Regulatory Information for done

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiamen Lp Pharm Co	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	216901-002	Jul 15, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm Industries	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	077975-001	Dec 11, 2009		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Aurobindo	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090056-001	May 31, 2011	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms Usa Inc	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	090175-001	May 10, 2011		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Natco Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090521-002	May 31, 2011		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Rx	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	078388-001	Nov 26, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Osmotica Pharm Us	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203114-001	Jan 26, 2016		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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