FDA — authorised 29 June 1998
- Application: NDA020865
- Marketing authorisation holder: ORGANON
- Local brand name: MAXALT-MLT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 RIZATRIPTAN BENZOATE in United States
FDA authorised RIZATRIPTAN BENZOATE on 29 June 1998 · 1,992 US adverse-event reports
Marketing authorisations
FDA — authorised 31 December 2012
- Application: ANDA201967
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA202047
- Marketing authorisation holder: CREEKWOOD PHARMS
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA201993
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA202490
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA079230
- Marketing authorisation holder: SANDOZ
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA200482
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA202244
- Marketing authorisation holder: APOTEX INC
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2012
- Application: ANDA077263
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2013
- Application: ANDA077526
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA203478
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA203062
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA078739
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA201914
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA204339
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2013
- Application: ANDA202477
- Marketing authorisation holder: APOTEX INC
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 26 November 2013
- Application: ANDA204090
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2014
- Application: ANDA203147
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2014
- Application: ANDA203252
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2015
- Application: ANDA203334
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 18 February 2016
- Application: ANDA203269
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2017
- Application: ANDA204722
- Marketing authorisation holder: PANACEA
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 7 March 2017
- Application: ANDA207836
- Marketing authorisation holder: UNICHEM
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2017
- Application: ANDA207835
- Marketing authorisation holder: UNICHEM
- Local brand name: RIZATRIPTAN BENZOATE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 14 April 2023
- Application: NDA205394
- Marketing authorisation holder: GENSCO
- Local brand name: RIZAFILM
- Indication: FILM — ORAL
- 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: 1,992
Most-reported reactions
- Drug Ineffective — 394 reports (19.78%)
- Headache — 246 reports (12.35%)
- Migraine — 238 reports (11.95%)
- Nausea — 220 reports (11.04%)
- Off Label Use — 195 reports (9.79%)
- Drug Intolerance — 150 reports (7.53%)
- Hypersensitivity — 143 reports (7.18%)
- Product Use In Unapproved Indication — 143 reports (7.18%)
- Fatigue — 138 reports (6.93%)
- Drug Ineffective For Unapproved Indication — 125 reports (6.28%)
RIZATRIPTAN BENZOATE 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 RIZATRIPTAN BENZOATE approved in United States?
Yes. FDA authorised it on 29 June 1998; FDA authorised it on 31 December 2012; FDA authorised it on 31 December 2012.
Who is the marketing authorisation holder for RIZATRIPTAN BENZOATE in United States?
ORGANON holds the US marketing authorisation.