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Last Updated: April 14, 2021

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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 Granules Pharms, Mayne Pharma Inc, Cnty Line Pharms, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, and Watson Labs, and is included in nine NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for 203484
Pharmacology for NDA: 203484
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 Larken Laboratories, Inc. 68047-721 68047-721-01 100 TABLET in 1 BOTTLE (68047-721-01)
ALLZITAL acetaminophen; butalbital TABLET;ORAL 203484 ANDA Larken Laboratories, Inc. 68047-721 68047-721-30 30 TABLET in 1 BOTTLE (68047-721-30)

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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