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BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LGM PHARMA · Approved 2001-11-30

Drug application

FDA Application #

ANDA075231

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Generic name

BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE

Active ingredients

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

LGM PHARMA

Manufacturer

LGM PHARMA SOLUTIONS, LLC

First approval

2001-11-30

Source

Authoritative

Drugs@FDA application overview

Machine

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