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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090956

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NDA 090956 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Mikart Inc, Cnty Line Pharms, Halsey, Larken Labs 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 090956
Tradename:BUTALBITAL AND ACETAMINOPHEN
Applicant:Nexgen Pharma
Ingredient:acetaminophen; butalbital
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090956
Ingredient-typeBarbiturates
Suppliers and Packaging for NDA: 090956
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 090956 ANDA ECR Pharmaceuticals 0095-3000 N 0095-3000-09
BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 090956 ANDA ECR Pharmaceuticals 0095-3000 N 0095-3000-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG;50MG
Approval Date:Aug 23, 2011TE:AARLD:No

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