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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 1986-03-17

Drug application

FDA Application #

ANDA089007

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

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

DR REDDYS LABS SA

Manufacturer

Mayne Pharma

First approval

1986-03-17

Source

Authoritative

Drugs@FDA application overview

Machine

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