FDA — authorised 28 August 1992
- Application: ANDA073618
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 CARBIDOPA AND LEVODOPA in United States
FDA authorised CARBIDOPA AND LEVODOPA on 28 August 1992
Marketing authorisations
FDA — authorised 28 August 1992
- Application: ANDA073589
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1992
- Application: ANDA073607
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 1993
- Application: ANDA074260
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1994
- Application: ANDA074080
- Marketing authorisation holder: SCS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 1995
- Application: ANDA073586
- Marketing authorisation holder: IDT AUSTRALIA LTD
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 1995
- Application: ANDA073587
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1999
- Application: ANDA075091
- Marketing authorisation holder: MYLAN
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076521
- Marketing authorisation holder: IMPAX LABS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 June 2004
- Application: ANDA076212
- Marketing authorisation holder: APOTEX
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 June 2004
- Application: ANDA076663
- Marketing authorisation holder: KV PHARM
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 August 2007
- Application: ANDA077828
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 June 2008
- Application: ANDA077120
- Marketing authorisation holder: APOTEX INC
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2008
- Application: ANDA078893
- Marketing authorisation holder: RISING
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 October 2008
- Application: ANDA078536
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2009
- Application: ANDA078690
- Marketing authorisation holder: SUN PHARM
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 28 September 2009
- Application: ANDA090324
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2010
- Application: ANDA090631
- Marketing authorisation holder: IMPAX LABS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 8 February 2013
- Application: ANDA202323
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 June 2019
- Application: ANDA210341
- Marketing authorisation holder: ALEMBIC
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 May 2021
- Application: ANDA214092
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2021
- Application: ANDA214091
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 September 2022
- Application: ANDA216505
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2022
- Application: ANDA216537
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 April 2023
- Application: ANDA215999
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 June 2024
- Application: ANDA217482
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 January 2025
- Application: ANDA218939
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA219989
- Marketing authorisation holder: SANDOZ INC
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: CAPSULE, EXTENDED RELEASE
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA219231
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: CAPSULE, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA073381
- Marketing authorisation holder: WATSON LABS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA073383
- Marketing authorisation holder: WATSON LABS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA220119
- Marketing authorisation holder: BIOCON PHARMA LIMITED
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: CAPSULE, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA073382
- Marketing authorisation holder: WATSON LABS
- Local brand name: CARBIDOPA AND LEVODOPA
- Indication: TABLET — ORAL
- Status: approved
CARBIDOPA AND LEVODOPA 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 CARBIDOPA AND LEVODOPA approved in United States?
Yes. FDA authorised it on 28 August 1992; FDA authorised it on 28 August 1992; FDA authorised it on 28 August 1992.
Who is the marketing authorisation holder for CARBIDOPA AND LEVODOPA in United States?
DR REDDYS LABS SA holds the US marketing authorisation.