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Last Updated: November 2, 2024

Done - Generic Drug Details

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Generic filers with tentative approvals for DONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Macleods Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202631-001	Jan 22, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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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