FDA — authorised 30 January 2009
- Application: ANDA078185
- Marketing authorisation holder: HIKMA
- Status: supplemented
🇺🇸 GALANTAMINE HYDROBROMIDE in United States
FDA authorised GALANTAMINE HYDROBROMIDE on 30 January 2009 · 4,052 US adverse-event reports
Marketing authorisations
FDA — authorised 24 January 2011
- Application: ANDA090900
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: GALANTAMINE HYDROBROMIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 February 2011
- Application: ANDA090178
- Marketing authorisation holder: SUN PHARM
- Local brand name: GALANTAMINE HYDROBROMIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 February 2011
- Application: ANDA078898
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: GALANTAMINE HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2011
- Application: ANDA077781
- Marketing authorisation holder: APOTEX INC
- Local brand name: GALANTAMINE HYDROBROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA077767
- Marketing authorisation holder: WATSON LABS
- Local brand name: GALANTAMINE HYDROBROMIDE
- Indication: TABLET — ORAL
- 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: 4,052
Most-reported reactions
- Fall — 502 reports (12.39%)
- Constipation — 420 reports (10.37%)
- Cognitive Disorder — 417 reports (10.29%)
- Hypotension — 411 reports (10.14%)
- Orthostatic Hypotension — 406 reports (10.02%)
- Balance Disorder — 405 reports (10%)
- Sedation — 383 reports (9.45%)
- Depressed Level Of Consciousness — 377 reports (9.3%)
- Pain — 369 reports (9.11%)
- Creatinine Renal Clearance Decreased — 362 reports (8.93%)
GALANTAMINE HYDROBROMIDE 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 GALANTAMINE HYDROBROMIDE approved in United States?
Yes. FDA authorised it on 30 January 2009; FDA authorised it on 24 January 2011; FDA authorised it on 2 February 2011.
Who is the marketing authorisation holder for GALANTAMINE HYDROBROMIDE in United States?
HIKMA holds the US marketing authorisation.