FDA — authorised 25 April 1977
- Application: NDA017830
- Marketing authorisation holder: ATON
- Indication: Type 3 - New Dosage Form
- Status: approved
🇺🇸 Sinemet Cr in United States
FDA authorised Sinemet Cr on 25 April 1977
Marketing authorisations
FDA — authorised 11 August 2000
- Application: ANDA075091
- Marketing authorisation holder: MYLAN
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 June 2003
- Application: NDA021485
- Marketing authorisation holder: ORION PHARMA
- Local brand name: STALEVO 100
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2005
- Application: ANDA076643
- Marketing authorisation holder: RANBAXY
- Local brand name: CARBILEV
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 July 2009
- Application: ANDA078690
- Marketing authorisation holder: SUN PHARM
- Status: approved
FDA — authorised 20 November 2012
- Application: ANDA090833
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2012
- Application: ANDA090786
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2013
- Application: ANDA202323
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 10 March 2014
- Application: ANDA203261
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 2016
- Application: ANDA205304
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Sinemet Cr for use in the United States on 2025-04-09. Sinemet Cr is a medication used in the treatment of Parkinson's disease and other conditions. The marketing authorisation was granted to EDENBRIDGE PHARMS under application number ANDA205304.
FDA — authorised 20 October 2017
- Application: ANDA204763
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 May 2018
- Application: ANDA209910
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA211055
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 2020
- Application: ANDA203424
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2021
- Application: NDA214869
- Marketing authorisation holder: AVION PHARMS
- Local brand name: DHIVY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2022
- Application: ANDA213212
- Marketing authorisation holder: RISING
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2023
- Application: ANDA217961
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: CARBIDOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 2024
- Application: NDA217186
- Marketing authorisation holder: IMPAX
- Local brand name: CREXONT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA214495
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2026
- Application: ANDA218535
- Marketing authorisation holder: ALEMBIC
- Local brand name: CARBIDOPA, LEVODOPA AND ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
Sinemet Cr 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 Sinemet Cr approved in United States?
Yes. FDA authorised it on 25 April 1977; FDA authorised it on 11 August 2000; FDA authorised it on 11 June 2003.
Who is the marketing authorisation holder for Sinemet Cr in United States?
ATON holds the US marketing authorisation.