FDA — authorised 4 October 1978
- Application: NDA018040
- Marketing authorisation holder: JANSSEN PHARMA
- Local brand name: MONISTAT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Monistat in United States
FDA authorised Monistat on 4 October 1978
Marketing authorisations
FDA — authorised 28 January 1998
- Application: ANDA074444
- Marketing authorisation holder: SUN PHARMA CANADA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 July 1998
- Application: NDA020827
- Marketing authorisation holder: MEDTECH PRODUCTS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 October 2002
- Application: NDA021261
- Marketing authorisation holder: MEDTECH PRODUCTS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 April 2011
- Application: NDA022404
- Marketing authorisation holder: GALT PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 21 August 2017
- Application: ANDA074760
- Marketing authorisation holder: PERRIGO
- Indication: Labeling
- Status: approved
Monistat 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 Monistat approved in United States?
Yes. FDA authorised it on 4 October 1978; FDA authorised it on 28 January 1998; FDA authorised it on 27 July 1998.
Who is the marketing authorisation holder for Monistat in United States?
JANSSEN PHARMA holds the US marketing authorisation.