FDA — authorised 28 October 1958
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Diabinese in United States
FDA authorised Diabinese on 28 October 1958
Marketing authorisations
FDA — authorised 10 July 1980
- Application: ANDA084669
- Marketing authorisation holder: SANDOZ
- Local brand name: CHLORPROPAMIDE
- 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 17 September 1984
- Application: ANDA088695
- Marketing authorisation holder: SUPERPHARM
- 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 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 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
- Application: ANDA088608
- Marketing authorisation holder: WATSON LABS
- 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: 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: ANDA088568
- Marketing authorisation holder: WATSON LABS
- Local brand name: CHLORPROPAMIDE
- Indication: TABLET — ORAL
- Status: approved
Diabinese 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 Diabinese approved in United States?
Yes. FDA authorised it on 28 October 1958; FDA authorised it on 10 July 1980; FDA authorised it on 1 June 1984.
Who is the marketing authorisation holder for Diabinese in United States?
PFIZER holds the US marketing authorisation.