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Serving hundreds of leading biopharmaceutical companies globally:

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US Department of Justice
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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040511

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NDA 040511 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 forty-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. Forty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 040511
Applicant:Vintage Pharms
Ingredient:acetaminophen; butalbital; caffeine
Formulation / Manufacturing:see details
Pharmacology for NDA: 040511
Suppliers and Packaging for NDA: 040511
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040511 ANDA KAISER FOUNDATION HOSPITALS 0179-0137 N 0179-0137-70
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040511 ANDA Par Pharmaceutical 0603-2544 N 0603-2544-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Aug 27, 2003TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts

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