← FDA DRUG APPROVALS

FDA NDA · NDA215320

COMBOGESIC IV

acetaminophen and ibuprofen injection

Sponsor: HIKMA

APPLICATION
NDA215320
TYPE
NDA
ORIGINAL APPROVAL
2023-10-17
LATEST ACTION
2024-11-21
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

COMBOGESIC IV · ReferencePrescription
ACETAMINOPHEN 1GM/100ML (10MG/ML), IBUPROFEN SODIUM EQ 300MG BASE/100ML (EQ 3MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-11-21Labeling · Supplement 1 · standard — Letter ↗AP
2023-10-17Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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