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BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: STEVENS J · Approved 1998-08-31

Drug application

FDA Application #

ANDA074951

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Generic name

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

Active ingredients

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

STEVENS J

Manufacturer

Amneal Pharmaceuticals of New York, LLC

First approval

1998-08-31

Source

Authoritative

Drugs@FDA application overview

Machine

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