Last Updated: May 11, 2026

Details for New Drug Application (NDA): 017601

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NDA 017601 describes OPTIMINE, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the OPTIMINE profile page.

The generic ingredient in OPTIMINE is azatadine maleate. There are two drug master file entries for this compound. Additional details are available on the azatadine maleate profile page.

Summary for 017601

Tradename:	OPTIMINE
Applicant:	Schering
Ingredient:	azatadine maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Expired US Patents for NDA 017601

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	OPTIMINE	azatadine maleate	TABLET;ORAL	017601-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Schering	OPTIMINE	azatadine maleate	TABLET;ORAL	017601-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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