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Details for New Drug Application (NDA): 018458

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NDA 018458 describes TALACEN, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the TALACEN profile page.

The generic ingredient in TALACEN is acetaminophen; pentazocine hydrochloride. There are sixty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the acetaminophen; pentazocine hydrochloride profile page.

Summary for NDA: 018458

Tradename:
TALACEN
Applicant:
Sanofi Aventis Us
Ingredient:
acetaminophen; pentazocine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;EQ 25MG BASE
Approval Date:Sep 23, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 018458

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
TALACEN
acetaminophen; pentazocine hydrochloride
TABLET;ORAL018458-001Sep 23, 19824,105,659► subscribe
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