FDA — authorised 10 June 1965
- Status: approved
🇺🇸 Indocin Sr in United States
FDA authorised Indocin Sr on 10 June 1965
Marketing authorisations
FDA — authorised 23 February 1982
- Application: NDA018185
- Marketing authorisation holder: ZYLA
- Local brand name: INDOCIN SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 April 2011
- Application: ANDA073314
- Marketing authorisation holder: COSETTE
- Indication: Labeling
- Status: approved
FDA — authorised 28 April 2021
- Application: NDA018332
- Marketing authorisation holder: ZYLA
- Indication: Labeling
- Status: approved
FDA — authorised 19 November 2024
- Application: ANDA215899
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 21 November 2024
- Application: ANDA091276
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Indocin Sr, manufactured by GLENMARK PHARMS LTD, for marketing in the United States on 2024-11-21. This approval was granted under the standard expedited pathway. The approved indication for Indocin Sr is for labeling purposes, indicating that the product's labeling has been reviewed and approved by the FDA.
FDA — authorised 24 February 2025
- Application: ANDA215399
- Marketing authorisation holder: AMNEAL
- Status: approved
Indocin Sr in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Indocin Sr approved in United States?
Yes. FDA authorised it on 10 June 1965; FDA authorised it on 23 February 1982; FDA authorised it on 29 April 2011.
Who is the marketing authorisation holder for Indocin Sr in United States?
Marketing authorisation holder not available in our data.