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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2018-11-07

Drug application

FDA Application #

ANDA211487

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Generic name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Active ingredients

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ASCENT PHARMS INC

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2018-11-07

Source

Authoritative

Drugs@FDA application overview

Machine

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