FDA — authorised 30 December 1982
- Marketing authorisation holder: MEDIMETRIKS PHARMS
- Status: approved
🇺🇸 Loprox in United States
FDA authorised Loprox on 30 December 1982
Marketing authorisations
FDA — authorised 30 December 1988
- Application: NDA019824
- Marketing authorisation holder: EUROFARMA
- Local brand name: LOPROX
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 28 February 2003
- Application: NDA021159
- Marketing authorisation holder: BAUSCH
- Local brand name: LOPROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 12 April 2005
- Application: ANDA076790
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CICLOPIROX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 August 2005
- Application: ANDA077092
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CICLOPIROX
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 3 March 2006
- Application: ANDA077364
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CICLOPIROX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 15 December 2006
- Application: ANDA077676
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: CICLOPIROX
- Indication: SUSPENSION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078124
- Marketing authorisation holder: RISING
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078270
- Marketing authorisation holder: HIKMA
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078144
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA077623
- Marketing authorisation holder: PADAGIS US
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078233
- Marketing authorisation holder: COSETTE
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078567
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA077687
- Marketing authorisation holder: ENCUBE
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078046
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078079
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 September 2007
- Application: ANDA078172
- Marketing authorisation holder: ACELLA
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 7 January 2009
- Application: ANDA078266
- Marketing authorisation holder: PADAGIS US
- Local brand name: CICLOPIROX
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 November 2009
- Application: ANDA090273
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: CICLOPIROX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 November 2009
- Application: ANDA090490
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CICLOPIROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 16 February 2010
- Application: ANDA078594
- Marketing authorisation holder: PADAGIS US
- Local brand name: CICLOPIROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 17 February 2010
- Application: ANDA078975
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CICLOPIROX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 25 May 2010
- Application: ANDA090146
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CICLOPIROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 23 February 2011
- Application: ANDA090269
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: CICLOPIROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 29 February 2012
- Application: ANDA091595
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: CICLOPIROX
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 5 April 2018
- Application: ANDA209975
- Marketing authorisation holder: ENCUBE
- Local brand name: CICLOPIROX
- Indication: SHAMPOO — TOPICAL
- Status: approved
Loprox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Loprox approved in United States?
Yes. FDA authorised it on 30 December 1982; FDA authorised it on 30 December 1988; FDA authorised it on 28 February 2003.
Who is the marketing authorisation holder for Loprox in United States?
MEDIMETRIKS PHARMS holds the US marketing authorisation.