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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NUVO PHARMS INC · Approved 2016-10-28

Drug application

FDA Application #

ANDA207118

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

NUVO PHARMS INC

Manufacturer

SUNRISE PHARMACEUTICAL, INC

First approval

2016-10-28

Source

Authoritative

Drugs@FDA application overview

Machine

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