General MedicationsORALStandard
COMBOGESIC
ACETAMINOPHEN; IBUPROFEN
Standard Dose
325MG;97.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview COMBOGESIC is listed in Drugs@FDA under application 209471 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; IBUPROFEN Form and strength TABLET;ORAL - 325MG;97.5MG Sponsor AFT PHARMS US Submission history Latest submission status date: 2024-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview COMBOGESIC is listed in Drugs@FDA under application 209471 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; IBUPROFEN Form and strength TABLET;ORAL - 325MG;97.5MG Sponsor AFT PHARMS US Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.