Details for New Drug Application (NDA): 019806

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NDA 019806 describes SEMPREX-D, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the SEMPREX-D profile page.

The generic ingredient in SEMPREX-D is acrivastine; pseudoephedrine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the acrivastine; pseudoephedrine hydrochloride profile page.

Summary for 019806

Tradename:	SEMPREX-D
Applicant:	Endo Operations
Ingredient:	acrivastine; pseudoephedrine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	8MG;60MG
Approval Date:	Mar 25, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 019806

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	⤷ Sign Up	⤷ Sign Up
Endo Operations	SEMPREX-D	acrivastine; pseudoephedrine hydrochloride	CAPSULE;ORAL	019806-001	Mar 25, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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