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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TRIS PHARMA INC · Approved 2021-12-30

Drug application

FDA Application #

ANDA201295

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

SOLUTION

Route

ORAL

Marketing status

Discontinued

Sponsor

TRIS PHARMA INC

Manufacturer

Cranbury Pharmaceuticals, LLC

First approval

2021-12-30

Source

Authoritative

Drugs@FDA application overview

Machine

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