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ROXICET 5/500

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ROXANE · Approved 1989-01-12

Drug application

FDA Application #

ANDA089775

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROXICET 5/500

Generic name

Acetaminophen

Active ingredients

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

ROXANE

First approval

1989-01-12

Source

Authoritative

Drugs@FDA application overview

Machine

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