FDA — authorised 14 December 1994
- Application: NDA020347
- Marketing authorisation holder: ABBOTT
- Local brand name: HYTRIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Hytrin in United States
FDA authorised Hytrin on 14 December 1994
Marketing authorisations
FDA — authorised 18 June 1999
- Application: ANDA074823
- Marketing authorisation holder: SENORES PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 December 2004
- Application: ANDA075317
- Marketing authorisation holder: JUBILANT CADISTA
- Status: approved
FDA — authorised 19 January 2024
- Application: ANDA075667
- Marketing authorisation holder: BIONPHARMA
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved BIONPHARMA's application (ANDA075667) for Hytrin on 19 January 2024. This approval is for the manufacturing (CMC) of the drug. The expedited pathway used was standard.
FDA — authorised 29 July 2024
- Application: NDA218139
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Hytrin, a product of Novitium Pharma, for a new dosage form on 29 July 2024. This approval was granted under the standard expedited pathway. The application number for this approval is NDA218139.
FDA — authorised 12 May 2025
- Application: ANDA219482
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
Hytrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Hytrin approved in United States?
Yes. FDA authorised it on 14 December 1994; FDA authorised it on 18 June 1999; FDA authorised it on 20 December 2004.
Who is the marketing authorisation holder for Hytrin in United States?
ABBOTT holds the US marketing authorisation.