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BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROLIFE PHARMA LLC · Approved 2018-09-26

Drug application

FDA Application #

ANDA204733

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

AUROLIFE PHARMA LLC

Manufacturer

Aurolife Pharma, LLC

First approval

2018-09-26

Source

Authoritative

Drugs@FDA application overview

Machine

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