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Last Updated: November 30, 2021

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, Lgm Pharma, Nostrum Labs Inc, and Strides Pharma, and is included in five NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Pharmacology for NDA: 076560
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 Breckenridge Pharmaceutical, Inc. 51991-073 51991-073-01 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-073-01)

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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