FDA — authorised 23 June 2006
- Application: ANDA076052
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 MK0733 in United States
FDA authorised MK0733 on 23 June 2006
Marketing authorisations
FDA — authorised 23 June 2006
- Application: ANDA076285
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2006
- Application: ANDA077691
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2006
- Application: ANDA078034
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2006
- Application: ANDA077752
- Marketing authorisation holder: RISING
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2006
- Application: ANDA077766
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2010
- Application: ANDA090868
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2014
- Application: ANDA200895
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2016
- Application: NDA206679
- Marketing authorisation holder: SALERNO PHARMS
- Local brand name: FLOLIPID
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 November 2024
- Application: ANDA211394
- Marketing authorisation holder: YILING
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA076532
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: SIMVASTATIN
- Indication: TABLET — ORAL
- Status: approved
MK0733 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 MK0733 approved in United States?
Yes. FDA authorised it on 23 June 2006; FDA authorised it on 23 June 2006; FDA authorised it on 20 December 2006.
Who is the marketing authorisation holder for MK0733 in United States?
IVAX SUB TEVA PHARMS holds the US marketing authorisation.