FDA — authorised 5 September 2007
- Application: ANDA076373
- Marketing authorisation holder: TEVA
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Coreg in United States
FDA authorised Coreg on 5 September 2007
Marketing authorisations
FDA — authorised 5 September 2007
- Application: ANDA078251
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA077316
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA078217
- Marketing authorisation holder: LUPIN
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA078227
- Marketing authorisation holder: SANDOZ
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA078384
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA076649
- Marketing authorisation holder: RISING
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA078332
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA077474
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA077780
- Marketing authorisation holder: TARO
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA078165
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 September 2007
- Application: ANDA077346
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2007
- Application: ANDA078240
- Marketing authorisation holder: PLIVA HRVATSKA DOO
- Local brand name: CARVEDILOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Coreg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Coreg approved in United States?
Yes. FDA authorised it on 5 September 2007; FDA authorised it on 5 September 2007; FDA authorised it on 5 September 2007.
Who is the marketing authorisation holder for Coreg in United States?
TEVA holds the US marketing authorisation.