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Generated: April 20, 2018

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Details for New Drug Application (NDA): 203484

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NDA 203484 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Mayne Pharma Inc, Cnty Line Pharms, Halsey, Larken Labs Inc, Mikart Inc, Nexgen Pharma, Tedor Pharma Inc, and Watson Labs, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.

The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 203484
Tradename:BUTALBITAL AND ACETAMINOPHEN
Applicant:Larken Labs Inc
Ingredient:acetaminophen; butalbital
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203484
Ingredient-typeBarbiturates
Suppliers and Packaging for NDA: 203484
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA STI Pharma LLC 54879-026 E 54879-026-01
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA Larken Laboratories, Inc. 68047-721 N 68047-721-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;25MG
Approval Date:Dec 4, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG
Approval Date:Dec 4, 2015TE:AARLD:No

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