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BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LGM PHARMA · Approved 2004-06-10

Drug application

FDA Application #

ANDA076560

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Generic name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE

Active ingredients

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

LGM PHARMA

Manufacturer

Actavis Pharma, Inc.

First approval

2004-06-10

Source

Authoritative

Drugs@FDA application overview

Machine

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