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Serving leading biopharmaceutical companies globally:

Julphar
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076560

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NDA 076560 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.
Pharmacology for NDA: 076560
Ingredient-typeBarbiturates
Xanthines
Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 076560
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 076560 ANDA Actavis Pharma, Inc. 0591-2641 0591-2641-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01)
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076560 ANDA Nexgen Pharma, Inc. 0722-6670 0722-6670-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0722-6670-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength325MG;50MG;40MG;30MG
Approval Date:Jun 10, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG;50MG;40MG;30MG
Approval Date:Jul 19, 2012TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Healthtrust
Fish and Richardson
Farmers Insurance
Cerilliant
Dow
Citi
Cantor Fitzgerald

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