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COMBOGESIC IV

NDA · New Drug Application · Sponsor: HIKMA · Approved 2023-10-17

Drug application

FDA Application #

NDA215320

Application type

New Drug Application

Brand name

COMBOGESIC IV

Generic name

ACETAMINOPHEN AND IBUPROFEN INJECTION

Active ingredients

ACETAMINOPHEN; IBUPROFEN SODIUM

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2023-10-17

Source

Authoritative

Drugs@FDA application overview

Machine

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