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NALBUPHINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-09-19

Drug application

FDA Application #

ANDA216050

Application type

Abbreviated New Drug Application (Generic)

Brand name

NALBUPHINE HYDROCHLORIDE

Generic name

NALBUPHINE HYDROCHLORIDE

Active ingredients

NALBUPHINE HYDROCHLORIDE

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2024-09-19

Source

Authoritative

Drugs@FDA application overview

Machine

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