FDA — authorised 22 December 1997
- Application: NDA020741
- Marketing authorisation holder: GEMINI LABS LLC
- Local brand name: PRANDIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Prandin in United States
FDA authorised Prandin on 22 December 1997
Marketing authorisations
FDA — authorised 17 July 2013
- Application: ANDA201189
- Marketing authorisation holder: PADAGIS US
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2013
- Application: ANDA090252
- Marketing authorisation holder: QUAGEN
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2013
- Application: ANDA078555
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Prandin for use in the United States on 2025-07-01. The marketing authorisation holder is CHARTWELL RX. The application was submitted under the standard expedited pathway.
FDA — authorised 22 January 2014
- Application: ANDA203820
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2014
- Application: ANDA090008
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2015
- Application: ANDA091517
- Marketing authorisation holder: KENTON
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2023
- Application: ANDA207209
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: REPAGLINIDE
- Indication: TABLET — ORAL
- Status: approved
Prandin 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 Prandin approved in United States?
Yes. FDA authorised it on 22 December 1997; FDA authorised it on 17 July 2013; FDA authorised it on 23 August 2013.
Who is the marketing authorisation holder for Prandin in United States?
GEMINI LABS LLC holds the US marketing authorisation.