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FIORICET W/ CODEINE

NDA · New Drug Application · Sponsor: ACTAVIS LABS UT INC · Approved 1992-07-30

Drug application

FDA Application #

NDA020232

Application type

New Drug Application

Brand name

FIORICET W/ CODEINE

Generic name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE

Active ingredients

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS UT INC

Manufacturer

Actavis Pharma, Inc.

First approval

1992-07-30

Source

Authoritative

Drugs@FDA application overview

Machine

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