FDA.reportPublic FDA data

Application 019957

Type
NDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CUTIVATEFLUTICASONE PROPIONATEOINTMENT;TOPICAL0.005%YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019957-001CUTIVATEFLUTICASONE PROPIONATE0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1990-12-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019957-001CUTIVATE0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1990-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019957-001CUTIVATE0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1990-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019957-001CUTIVATE0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1990-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019957-001CUTIVATE0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD1990-12-14a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluticasoneFLUTICASONE PROPIONATEYYBA CORP535b2575-8af8-d951-e063-6394a90ac72d2026-09-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEGlenmark Pharmaceuticals Inc., USAbc08915f-fa3a-4509-a01c-42b577f39b992026-08-19Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-08-17WarningsName fallback
generic name: FLUTICASONE PROPIONATE
TopCare Childrens Allergy Relief Nasal 24 HourFLUTICASONE PROPIONATETopco Associates LLC3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a92026-08-11WarningsName fallback
generic name: FLUTICASONE PROPIONATE
CHILDRENS ALLERGY RELIEFFLUTICASONE PROPIONATEWalgreen Company2e81a611-15c2-466e-a111-8ecf939b95602026-08-11WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company6f3f64e6-d1f8-40d7-bb25-f6f279db99872026-08-11WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Equate Allergy ReliefFLUTICASONE PROPIONATEWALMART INC.bc824143-b876-4c3d-86fd-81fb586738512026-08-10WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEGolden State Medical Supply, Inc.534d78c5-4ba0-4ab1-e063-6294a90a8ff72026-08-05Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
ALLERGY RELIEF NASALFLUTICASONE PROPIONATEAmazon.com Services LLCdc552613-5cfe-4de3-b2c0-79703316758a2026-07-30WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEThe Kroger Co.f05689fa-7ff3-0846-c647-bdbe79cb2ff82026-07-29WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATESportpharm LLC348cbd8c-edeb-499c-961d-3aeb5cc2cef12026-07-28Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEP & L Development, LLCe3347976-facd-49b6-9ae1-7ed3cd02ba962026-07-02WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEChain Drug Marketing Association, Inc.0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc72026-07-02WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Childrens Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEGLENMARK THERAPEUTICS INC., USA9aaa30cf-1e3b-4382-91dc-568067a4b0ac2026-06-30WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEFamily Dollar Stores, LLC4dd65267-9905-4f45-e063-6294a90a25162026-06-17WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate ALLERGY RELIEFFLUTICASONE PROPIONATEYYBA CORP5348075c-63ca-20f7-e063-6394a90a3f5c2026-06-12WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEPreferred Pharmaceuticals Inc.8225d521-f1f7-4d21-9095-9a2e1833d1bf2026-06-08Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
allergy relief nasalFLUTICASONE PROPIONATEHyVee Incc3327be1-e4a9-4b02-968d-eff5e18cbc842026-06-03WarningsName fallback
generic name: FLUTICASONE PROPIONATE
allergy nasalFLUTICASONE PROPIONATERite Aid Corporatione471dacd-9b6e-4783-9a14-aa95d00cbc9c2026-06-03WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEYYBA Corp5333562e-9d8e-2618-e063-6394a90a86732026-06-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10337-333Cutivatefluticasone propionatePharmaDerm a division of Fougera Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66846SUPPL2021-03-24
66821SUPPL2021-03-22
34145SUPPL2015-02-20
19893SUPPL2015-02-19
12100SUPPL2004-06-02
34144SUPPL2003-06-10
12099SUPPL2003-06-10
1852SUPPL2003-04-08