FDA — authorised 10 July 1974
- Application: NDA012678
- Marketing authorisation holder: SANDOZ
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Sulfonylureas in United States
FDA authorised Sulfonylureas on 10 July 1974
Marketing authorisations
FDA — authorised 30 January 1979
- Application: ANDA086109
- Marketing authorisation holder: WATSON LABS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 1979
- Application: ANDA086445
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 1979
- Application: ANDA086141
- Marketing authorisation holder: ALRA
- 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 5 February 1980
- Application: ANDA086926
- Marketing authorisation holder: DAVA PHARMS INC
- 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 10 July 1980
- Application: ANDA084669
- Marketing authorisation holder: SANDOZ
- Local brand name: CHLORPROPAMIDE
- 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 31 March 1981
- Application: ANDA087318
- Marketing authorisation holder: WATSON LABS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 1981
- Application: ANDA087353
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- 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 1 June 1984
- Application: ANDA088549
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 1984
- Application: ANDA088725
- Marketing authorisation holder: RISING
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 1984
- Application: ANDA088726
- Marketing authorisation holder: RISING
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 1984
- Application: ANDA088695
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1984
- Application: ANDA086865
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 1984
- Application: ANDA088852
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 1984
- Application: ANDA088641
- Marketing authorisation holder: ANI PHARMS
- Local brand name: GLUCAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 October 1984
- Application: ANDA088768
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 1984
- Application: ANDA088918
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 1984
- Application: ANDA088919
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 1984
- Application: ANDA088840
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- 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 — authorised 12 April 1985
- Application: ANDA088922
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 1985
- Application: ANDA088921
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 September 1985
- Application: ANDA086866
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA089447
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA089446
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088709
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089111
- Marketing authorisation holder: WATSON LABS
- Local brand name: TOLBUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089110
- Marketing authorisation holder: WATSON LABS
- 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
FDA
- Application: ANDA088608
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088568
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088662
- Marketing authorisation holder: HALSEY
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088694
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089321
- Marketing authorisation holder: HALSEY
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089562
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089561
- Marketing authorisation holder: DAVA PHARMS INC
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088708
- Marketing authorisation holder: USL PHARMA
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
Sulfonylureas in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Sulfonylureas approved in United States?
Yes. FDA authorised it on 10 July 1974; FDA authorised it on 30 January 1979; FDA authorised it on 10 April 1979.
Who is the marketing authorisation holder for Sulfonylureas in United States?
SANDOZ holds the US marketing authorisation.