FDA — authorised 5 November 1953
- Application: NDA009087
- Marketing authorisation holder: NOVARTIS
- Local brand name: HYDERGINE
- Indication: TABLET — SUBLINGUAL
- Status: approved
🇺🇸 Hydergine in United States
FDA authorised Hydergine on 5 November 1953
Marketing authorisations
FDA — authorised 5 November 1953
- Marketing authorisation holder: NOVARTIS
- Status: approved
FDA — authorised 28 December 1976
- Application: ANDA084868
- Marketing authorisation holder: 3M
- Local brand name: CIRCANOL
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 28 December 1977
- Application: ANDA085809
- Marketing authorisation holder: 3M
- Local brand name: CIRCANOL
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 30 December 1977
- Application: NDA017993
- Marketing authorisation holder: NOVARTIS
- Local brand name: HYDERGINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 1980
- Application: ANDA086188
- Marketing authorisation holder: WATSON LABS
- Local brand name: GERIMAL
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 7 July 1980
- Application: ANDA086189
- Marketing authorisation holder: WATSON LABS
- Local brand name: GERIMAL
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 20 November 1980
- Application: ANDA087186
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDROGENATED ERGOT ALKALOIDS
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 20 November 1980
- Application: ANDA087185
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDROGENATED ERGOT ALKALOIDS
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 30 January 1981
- Application: NDA018418
- Marketing authorisation holder: NOVARTIS
- Local brand name: HYDERGINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 April 1981
- Application: ANDA087233
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 16 April 1981
- Application: ANDA087183
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 11 August 1981
- Application: ANDA087407
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 11 August 1981
- Application: ANDA087552
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA087244
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 September 1982
- Application: ANDA088013
- Marketing authorisation holder: VANGARD
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 20 September 1982
- Application: ANDA088014
- Marketing authorisation holder: VANGARD
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 1 November 1985
- Application: ANDA088891
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1991
- Application: ANDA081113
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1994
- Application: ANDA087417
- Marketing authorisation holder: SANDOZ
- Local brand name: ALKERGOT
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 16 September 1994
- Application: ANDA085153
- Marketing authorisation holder: SANDOZ
- Local brand name: ALKERGOT
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA086433
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089233
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA085900
- Marketing authorisation holder: KV PHARM
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA089234
- Marketing authorisation holder: SUPERPHARM
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA085020
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: DEAPRIL-ST
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA085177
- Marketing authorisation holder: WATSON LABS
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA088207
- Marketing authorisation holder: WATSON LABS
- Local brand name: GERIMAL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085899
- Marketing authorisation holder: KV PHARM
- Local brand name: ERGOLOID MESYLATES
- Indication: TABLET — SUBLINGUAL
- Status: approved
Hydergine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Hydergine approved in United States?
Yes. FDA authorised it on 5 November 1953; FDA authorised it on 5 November 1953; FDA authorised it on 28 December 1976.
Who is the marketing authorisation holder for Hydergine in United States?
NOVARTIS holds the US marketing authorisation.