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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Novartis
Chinese Patent Office
Fish and Richardson
Harvard Business School
Fuji
AstraZeneca
Argus Health
Federal Trade Commission

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075929

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NDA 075929 describes BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, which is a drug marketed by Able, Hikma Intl Pharms, Nexgen Pharma Inc, and Vintage Pharms, and is included in four NDAs. It is available from seven suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Summary for 075929
Pharmacology for NDA: 075929
Ingredient-typeBarbiturates
Xanthines
Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 075929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075929 ANDA Par Pharmaceutical 0603-2553 0603-2553-21 100 CAPSULE in 1 BOTTLE, PLASTIC (0603-2553-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Apr 22, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fuji
Dow
Argus Health
Daiichi Sankyo
Medtronic
Colorcon
Boehringer Ingelheim
Cipla

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