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BUTALBITAL AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS SA · Approved 2017-12-27

Drug application

FDA Application #

ANDA207313

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTALBITAL AND ACETAMINOPHEN

Generic name

BUTALBITAL AND ACETAMINOPHEN

Active ingredients

ACETAMINOPHEN; BUTALBITAL

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

DR REDDYS LABS SA

Manufacturer

Dr. Reddy's Labratories Inc.

First approval

2017-12-27

Source

Authoritative

Drugs@FDA application overview

Machine

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