FDA — authorised 22 June 1961
- Status: approved
🇺🇸 Aglicid in United States
FDA authorised Aglicid on 22 June 1961
Marketing authorisations
FDA — authorised 10 July 1974
- Application: NDA012678
- Marketing authorisation holder: SANDOZ
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 1979
- Application: ANDA086109
- Marketing authorisation holder: WATSON LABS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 1979
- Application: ANDA086047
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1980
- Application: ANDA087093
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 1980
- Application: ANDA086574
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 1981
- Application: ANDA087121
- Marketing authorisation holder: BARR
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 1983
- Application: ANDA087541
- Marketing authorisation holder: ASCOT
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 1984
- Application: ANDA088893
- Marketing authorisation holder: SUPERPHARM
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 March 1985
- Application: ANDA087876
- Marketing authorisation holder: VANGARD
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088950
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
Aglicid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Aglicid approved in United States?
Yes. FDA authorised it on 22 June 1961; FDA authorised it on 10 July 1974; FDA authorised it on 30 January 1979.
Who is the marketing authorisation holder for Aglicid in United States?
Marketing authorisation holder not available in our data.