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OXYCODONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS · Approved 2003-09-04

Drug application

FDA Application #

ANDA076318

Application type

Abbreviated New Drug Application (Generic)

Brand name

OXYCODONE HYDROCHLORIDE

Generic name

Oxycodone Hydrochloride

Active ingredients

OXYCODONE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

None (Tentative Approval)

Sponsor

IMPAX LABS

First approval

2003-09-04

Source

Authoritative

Drugs@FDA application overview

Machine

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