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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2008-12-01

Drug application

FDA Application #

ANDA040864

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

GRANULES

Manufacturer

Granules Pharmaceuticals Inc.

First approval

2008-12-01

Source

Authoritative

Drugs@FDA application overview

Machine

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