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HYDROMORPHONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ASCENT PHARMS INC · Approved 2020-09-23

Drug application

FDA Application #

ANDA212133

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROMORPHONE HYDROCHLORIDE

Generic name

HYDROMORPHONE HYDROCHLORIDE

Active ingredients

HYDROMORPHONE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ASCENT PHARMS INC

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2020-09-23

Source

Authoritative

Drugs@FDA application overview

Machine

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