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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 Cnty Line Pharms, Watson Labs, Nexgen Pharma, Halsey, Larken Labs Inc, and Mikart Inc, and is included in six NDAs. It is available from six 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-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

Summary for NDA: 203484

Tradename:
ALLZITAL
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 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. 68047-722 68047-722-01 100 TABLET in 1 BOTTLE (68047-722-01)

Summary for product number 001

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

Summary for product number 002

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


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