FDA — authorised 16 December 1986
- Application: ANDA070975
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Status: supplemented
🇺🇸 Placebo "30, 50 or 70 mg" in United States
FDA authorised Placebo "30, 50 or 70 mg" on 16 December 1986 · 4,718,320 US adverse-event reports
Marketing authorisations
FDA — authorised 1 December 2011
- Application: NDA200403
- Marketing authorisation holder: HOSPIRA INC
- Status: supplemented
FDA — authorised 27 October 2016
- Application: ANDA206543
- Marketing authorisation holder: LUOXIN AUROVITAS
- Status: approved
FDA — authorised 25 May 2017
- Application: ANDA203821
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 21 March 2025
- Application: ANDA219883
- Marketing authorisation holder: ANTHEA PHARMA
- 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: 22 April 2025 – 22 April 2026
- Total reports: 4,718,320
Most-reported reactions
- Drug Ineffective — 802,300 reports (17%)
- Off Label Use — 530,285 reports (11.24%)
- Nausea — 518,631 reports (10.99%)
- Fatigue — 504,212 reports (10.69%)
- Diarrhoea — 438,337 reports (9.29%)
- Death — 428,633 reports (9.08%)
- Headache — 399,609 reports (8.47%)
- Pain — 384,776 reports (8.15%)
- Dyspnoea — 380,451 reports (8.06%)
- Dizziness — 331,086 reports (7.02%)
Placebo "30, 50 or 70 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 Placebo "30, 50 or 70 mg" approved in United States?
Yes. FDA authorised it on 16 December 1986; FDA authorised it on 1 December 2011; FDA authorised it on 27 October 2016.
Who is the marketing authorisation holder for Placebo "30, 50 or 70 mg" in United States?
ACTAVIS ELIZABETH holds the US marketing authorisation.