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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS UT INC · Approved 1984-11-09

Drug application

FDA Application #

ANDA088616

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Generic name

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE

Active ingredients

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS UT INC

Manufacturer

Actavis Pharma, Inc.

First approval

1984-11-09

Source

Authoritative

Drugs@FDA application overview

Machine

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