FDA — authorised 8 July 1964
- Application: ANDA060577
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: TABLET — VAGINAL
- Status: approved
🇺🇸 Mycostatin in United States
FDA authorised Mycostatin on 8 July 1964
Marketing authorisations
FDA — authorised 8 September 1964
- Application: ANDA060578
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 16 September 1964
- Application: ANDA060574
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 February 1965
- Application: ANDA060575
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 April 1987
- Application: NDA050619
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: PASTILLE — ORAL
- Status: approved
FDA — authorised 30 April 1996
- Application: ANDA064022
- Marketing authorisation holder: SUN PHARMA CANADA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 August 1996
- Application: ANDA064118
- Marketing authorisation holder: PADAGIS US
- Local brand name: NYSTOP
- Indication: POWDER — TOPICAL
- Status: approved
FDA — authorised 3 May 2005
- Application: ANDA065183
- Marketing authorisation holder: UPSHER SMITH LABS
- Status: approved
FDA — authorised 6 October 2017
- Application: ANDA209114
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 28 January 2019
- Application: ANDA211838
- Marketing authorisation holder: TORRENT
- Status: approved
FDA — authorised 24 July 2019
- Application: ANDA212557
- Marketing authorisation holder: TORRENT
- Status: approved
FDA
- Application: ANDA060571
- Marketing authorisation holder: DELCOR ASSET CORP
- Local brand name: MYCOSTATIN
- Indication: OINTMENT — TOPICAL
- Status: approved
Mycostatin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Mycostatin approved in United States?
Yes. FDA authorised it on 8 July 1964; FDA authorised it on 8 September 1964; FDA authorised it on 16 September 1964.
Who is the marketing authorisation holder for Mycostatin in United States?
DELCOR ASSET CORP holds the US marketing authorisation.