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Details for New Drug Application (NDA): 074699

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NDA 074699 describes ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE, which is a drug marketed by Gavis Pharms and Watson Labs and is included in two NDAs. It is available from two suppliers. Additional details are available on the ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE profile page.

The generic ingredient in ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE 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: 074699

Tradename:
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
Applicant:
Watson Labs
Ingredient:
acetaminophen; pentazocine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 074699

Suppliers and Packaging for NDA: 074699

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
acetaminophen; pentazocine hydrochloride
TABLET;ORAL 074699 ANDA Rebel Distributors Corp 21695-634 21695-634-60 60 TABLET in 1 BOTTLE (21695-634-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;EQ 25MG BASE
Approval Date:Mar 24, 2000TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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