FDA — authorised 3 February 1975
- Application: NDA017613
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: LOTRIMIN
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 Lotrimin in United States
FDA authorised Lotrimin on 3 February 1975
Marketing authorisations
FDA — authorised 18 March 1975
- Application: NDA017619
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: LOTRIMIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 January 1979
- Application: NDA018183
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: MYCELEX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 January 1979
- Application: NDA018181
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MYCELEX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 February 1979
- Application: NDA018230
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: MYCELEX-7
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 27 February 1979
- Application: NDA018182
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: MYCELEX-7
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 17 June 1983
- Application: NDA018713
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MYCELEX
- Indication: TROCHE/LOZENGE — ORAL
- Status: approved
FDA — authorised 17 February 1984
- Application: NDA018813
- Marketing authorisation holder: SCHERING
- Local brand name: LOTRIMIN
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 27 October 1989
- Application: NDA020889
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: LOTRIMIN AF
- Indication: Lotion — Topical
- Status: approved
FDA — authorised 27 October 1989
- Application: NDA020890
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: LOTRIMIN AF
- Indication: Solution — Topical
- Status: approved
FDA — authorised 27 October 1989
- Application: NDA020888
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: LOTRIMIN AF
- Indication: Cream — Topical
- Status: approved
FDA — authorised 16 July 1993
- Application: ANDA074165
- Marketing authorisation holder: P AND L
- Local brand name: CLOTRIMAZOLE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 31 August 1993
- Application: ANDA072640
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOTRIMAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 23 June 1994
- Application: NDA020389
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: MYCELEX-7 COMBINATION PACK
- Indication: CREAM, TABLET — TOPICAL, VAGINAL
- Status: approved
FDA — authorised 28 February 1995
- Application: ANDA073306
- Marketing authorisation holder: TEVA
- Local brand name: CLOTRIMAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 4 December 1995
- Application: ANDA072641
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOTRIMAZOLE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 29 July 1996
- Application: NDA020526
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: GYNE-LOTRIMIN 3 COMBINATION PACK
- Indication: CREAM, TABLET — TOPICAL, VAGINAL
- Status: approved
FDA — authorised 29 July 1996
- Application: NDA020525
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: GYNE-LOTRIMIN 3
- Indication: TABLET — VAGINAL
- Status: approved
FDA — authorised 29 July 1996
- Application: ANDA074580
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CLOTRIMAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 12 April 2000
- Application: NDA021143
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TRIVAGIZOLE 3
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 28 October 2005
- Application: ANDA076763
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLOTRIMAZOLE
- Indication: TROCHE/LOZENGE — ORAL
- Status: approved
FDA — authorised 2 September 2008
- Application: ANDA078338
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CLOTRIMAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 August 2010
- Application: ANDA090219
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: CLOTRIMAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 February 2019
- Application: ANDA209815
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA — authorised 25 July 2019
- Application: ANDA212281
- Marketing authorisation holder: TP ANDA HOLDINGS
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA075673
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA076002
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Indication: Labeling
- Status: approved
FDA — authorised 16 October 2023
- Application: ANDA216569
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: CLOTRIMAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 February 2024
- Application: ANDA215641
- Marketing authorisation holder: THINQ PHARM-CRO PVT
- Local brand name: CLOTRIMAZOLE
- Indication: TROCHE/LOZENGE — ORAL
- Status: approved
FDA — authorised 26 September 2025
- Application: NDA217628
- Marketing authorisation holder: CARWIN PHARM ASSOC
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Lotrimin, a product of CARWIN PHARM ASSOC, on 26 September 2025. The approval was granted under the new dosage form indication (Type 3) and was processed through the standard expedited pathway. This approval allows CARWIN PHARM ASSOC to market Lotrimin in the United States.
FDA
- Application: NDA019069
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: MYCELEX-G
- Indication: TABLET — VAGINAL
- Status: approved
Lotrimin 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 Lotrimin approved in United States?
Yes. FDA authorised it on 3 February 1975; FDA authorised it on 18 March 1975; FDA authorised it on 15 January 1979.
Who is the marketing authorisation holder for Lotrimin in United States?
SCHERING PLOUGH holds the US marketing authorisation.