FDA — authorised 18 May 1984
- Application: NDA018989
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ibuprofen 200 mg in United States
FDA authorised Ibuprofen 200 mg on 18 May 1984 · 192 US adverse-event reports
Marketing authorisations
FDA — authorised 26 June 2009
- Application: ANDA079205
- Marketing authorisation holder: MARKSANS PHARMA
- Status: supplemented
FDA — authorised 10 December 2010
- Application: ANDA079174
- Marketing authorisation holder: GRANULES INDIA
- Status: approved
FDA — authorised 28 March 2011
- Application: ANDA079129
- Marketing authorisation holder: STRIDES PHARMA
- Status: supplemented
FDA — authorised 12 June 2012
- Application: NDA201803
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ADVIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2024
- Application: ANDA211404
- Marketing authorisation holder: PLD ACQUISITIONS LLC
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 192
Most-reported reactions
- Angioedema — 29 reports (15.1%)
- Intentional Overdose — 26 reports (13.54%)
- Death — 22 reports (11.46%)
- Hypotension — 20 reports (10.42%)
- Vomiting — 19 reports (9.9%)
- Metabolic Acidosis — 17 reports (8.85%)
- Foetal Exposure During Pregnancy — 16 reports (8.33%)
- Urticaria — 16 reports (8.33%)
- Dyspnoea — 14 reports (7.29%)
- Anaphylactic Reaction — 13 reports (6.77%)
Ibuprofen 200 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Ibuprofen 200 mg approved in United States?
Yes. FDA authorised it on 18 May 1984; FDA authorised it on 26 June 2009; FDA authorised it on 10 December 2010.
Who is the marketing authorisation holder for Ibuprofen 200 mg in United States?
HALEON US HOLDINGS holds the US marketing authorisation.