Details for New Drug Application (NDA): 016891

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NDA 016891 describes TALWIN COMPOUND, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the TALWIN COMPOUND profile page.

The generic ingredient in TALWIN COMPOUND is aspirin; pentazocine hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; pentazocine hydrochloride profile page.

Summary for 016891

Tradename:	TALWIN COMPOUND
Applicant:	Sanofi Aventis Us
Ingredient:	aspirin; pentazocine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016891

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TALWIN COMPOUND	aspirin; pentazocine hydrochloride	TABLET;ORAL	016891-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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