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Serving leading biopharmaceutical companies globally:

Fuji
AstraZeneca
McKesson
Baxter
Novartis
UBS
Fish and Richardson
US Army
Express Scripts
Dow

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040496

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NDA 040496 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by 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, Gilbert Labs, Lannett Holdings Inc, Mallinckrodt Inc, Mirror Pharms Llc, Novast Labs Ltd, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in twenty-eight NDAs. It is available from forty-nine 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-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.
Summary for 040496
Tradename:BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:Mikart
Ingredient:acetaminophen; butalbital; caffeine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040496
Suppliers and Packaging for NDA: 040496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040496 ANDA Rebel Distributors Corp 21695-843 21695-843-60 60 TABLET in 1 BOTTLE (21695-843-60)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG;50MG;40MG
Approval Date:Dec 23, 2003TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
UBS
Accenture
Cerilliant
Deloitte
QuintilesIMS
Dow
Fuji

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