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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Cantor Fitzgerald
Cipla
US Army
Chinese Patent Office
Chubb
Johnson and Johnson
Cerilliant

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040885

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NDA 040885 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Gilbert Labs, Graham Dm, Hikma Pharms, Mallinckrodt, Mayne Pharma Inc, Nexgen Pharma, Nuvo Pharm Inc, Tedor Pharma Inc, Mikart, Able, Actavis Labs Ut Inc, Cnty Line Pharms, Lannett Holdings Inc, Mirror Pharms Llc, Novast Labs Ltd, Specgx Llc, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in twenty-nine NDAs. It is available from thirty-eight suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 040885
Tradename:BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:Nexgen Pharma
Ingredient:acetaminophen; butalbital; caffeine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040885
Suppliers and Packaging for NDA: 040885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885 ANDA Actavis Pharma, Inc. 0591-2640 N 0591-2640-01
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885 ANDA Actavis Pharma, Inc. 0591-2640 N 0591-2640-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;50MG;40MG
Approval Date:Nov 16, 2009TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Colorcon
QuintilesIMS
Accenture
Medtronic
US Army
Merck
Farmers Insurance
Fish and Richardson

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