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BUTALBITAL AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2019-11-22

Drug application

FDA Application #

ANDA213115

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

GRANULES

Manufacturer

Granules Pharmaceuticals Inc.

First approval

2019-11-22

Source

Authoritative

Drugs@FDA application overview

Machine

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