FDA — authorised 14 May 2004
- Application: ANDA076793
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUTICASONE PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 FPNS in United States
FDA authorised FPNS on 14 May 2004
Marketing authorisations
FDA — authorised 14 May 2004
- Application: ANDA076300
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FLUTICASONE PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076451
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: FLUTICASONE PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 September 2004
- Application: ANDA076865
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: FLUTICASONE PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 June 2005
- Application: ANDA077145
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: FLUTICASONE PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 22 February 2006
- Application: ANDA076504
- Marketing authorisation holder: HIKMA
- Local brand name: FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 3 March 2006
- Application: ANDA077168
- Marketing authorisation holder: COSETTE
- Local brand name: FLUTICASONE PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 June 2006
- Application: ANDA077055
- Marketing authorisation holder: COSETTE
- Local brand name: FLUTICASONE PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 April 2007
- Application: NDA022051
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: FLONASE SENSIMIST ALLERGY RELIEF
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 2 May 2011
- Application: ANDA090759
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FLUTICASONE PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 30 July 2013
- Application: ANDA091553
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUTICASONE PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 26 May 2016
- Application: ANDA207957
- Marketing authorisation holder: HIKMA
- Local brand name: FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 18 September 2017
- Application: NDA209022
- Marketing authorisation holder: PARATEK PHARMS
- Local brand name: XHANCE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 17 April 2019
- Application: ANDA208024
- Marketing authorisation holder: HIKMA
- Local brand name: FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 13 December 2021
- Application: ANDA213948
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 1 September 2023
- Application: ANDA215343
- Marketing authorisation holder: BRIGHT
- Local brand name: FLUTICASONE PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 5 June 2025
- Application: ANDA218321
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 12 January 2026
- Application: ANDA214464
- Marketing authorisation holder: RESPIRENT PHARMS
- Local brand name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 16 March 2026
- Application: ANDA218742
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: FLUTICASONE PROPIONATE
- Indication: SPRAY, METERED — NASAL
- Status: approved
The FDA approved GLENMARK SPECLT's application (ANDA218742) for FLUTICASONE PROPIONATE (FPNS) on 16 March 2026. This approval allows GLENMARK SPECLT to market FPNS as a nasal spray for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis. The approval was granted through the standard expedited pathway.
FDA
- Status: approved
FPNS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is FPNS approved in United States?
Yes. FDA authorised it on 14 May 2004; FDA authorised it on 14 May 2004; FDA authorised it on 14 May 2004.
Who is the marketing authorisation holder for FPNS in United States?
PADAGIS ISRAEL holds the US marketing authorisation.