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BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2022-01-26

Drug application

FDA Application #

ANDA215138

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Generic name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Active ingredients

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2022-01-26

Source

Authoritative

Drugs@FDA application overview

Machine

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