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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2012-09-06

Drug application

FDA Application #

ANDA090460

Application type

Abbreviated New Drug Application (Generic)

Brand name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Generic name

Acetaminophen

Active ingredients

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS USA INC

First approval

2012-09-06

Source

Authoritative

Drugs@FDA application overview

Machine

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