FDA — authorised 20 May 2019
- Application: ANDA210224
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
🇺🇸 SOLIFENACIN SUCCINATE in United States
FDA authorised SOLIFENACIN SUCCINATE on 20 May 2019 · 1,018 US adverse-event reports
Marketing authorisations
FDA — authorised 20 May 2019
- Application: ANDA210281
- Marketing authorisation holder: BOSTAL
- Status: approved
FDA — authorised 26 May 2020
- Application: NDA209529
- Marketing authorisation holder: ASTELLAS
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 24 November 2020
- Application: ANDA209239
- Marketing authorisation holder: GLENMARK SPECLT
- Indication: Labeling
- Status: approved
FDA — authorised 3 December 2021
- Application: ANDA211657
- Marketing authorisation holder: SCIEGEN PHARMS
- Indication: Labeling
- 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: 1,018
Most-reported reactions
- Fall — 138 reports (13.56%)
- Fatigue — 137 reports (13.46%)
- Dizziness — 103 reports (10.12%)
- Malaise — 103 reports (10.12%)
- Nausea — 97 reports (9.53%)
- Drug Ineffective — 96 reports (9.43%)
- Diarrhoea — 95 reports (9.33%)
- Headache — 93 reports (9.14%)
- Constipation — 82 reports (8.06%)
- Hypotension — 74 reports (7.27%)
SOLIFENACIN SUCCINATE 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 SOLIFENACIN SUCCINATE approved in United States?
Yes. FDA authorised it on 20 May 2019; FDA authorised it on 20 May 2019; FDA authorised it on 26 May 2020.
Who is the marketing authorisation holder for SOLIFENACIN SUCCINATE in United States?
ALKEM LABS LTD holds the US marketing authorisation.