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BUTAPAP

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MIKART · Approved 1992-10-26

Drug application

FDA Application #

ANDA089987

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUTAPAP

Generic name

BUTALBITAL AND ACETAMINOPHEN

Active ingredients

ACETAMINOPHEN; BUTALBITAL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MIKART

Manufacturer

Endo USA

First approval

1992-10-26

Source

Authoritative

Drugs@FDA application overview

Machine

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