Home Applications 021152 Application 021152
Type NDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CUTIVATE FLUTICASONE PROPIONATE LOTION;TOPICAL 0.05% Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021152-001 CUTIVATE FLUTICASONE PROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021152-001 CUTIVATE 0.05% LOTION / TOPICAL RLD 2005-03-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021152-001 CUTIVATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LOTION / TOPICAL RLD 2005-03-31 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021152-001 7300669 2019-10-20 U-835 Drug product 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021152-001 7300669 2019-10-20 U-835 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021152-001 7300669 2019-10-20 U-835 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021152-001 7300669 2019-10-20 U-835 Drug product ea99ee380514…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fluticasone FLUTICASONE PROPIONATE YYBA CORP 535b2575-8af8-d951-e063-6394a90ac72d 2026-09-01 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Glenmark Pharmaceuticals Inc., USA bc08915f-fa3a-4509-a01c-42b577f39b99 2026-08-19 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Walgreens 16756136-e813-8a91-3351-7e759d1b4b94 2026-08-17 Warnings Name fallback generic name: FLUTICASONE PROPIONATE TopCare Childrens Allergy Relief Nasal 24 Hour FLUTICASONE PROPIONATE Topco Associates LLC 3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a9 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE CHILDRENS ALLERGY RELIEF FLUTICASONE PROPIONATE Walgreen Company 2e81a611-15c2-466e-a111-8ecf939b9560 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Good Sense 24 hour allergy nasal FLUTICASONE PROPIONATE L. Perrigo Company 6f3f64e6-d1f8-40d7-bb25-f6f279db9987 2026-08-11 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Equate Allergy Relief FLUTICASONE PROPIONATE WALMART INC. bc824143-b876-4c3d-86fd-81fb58673851 2026-08-10 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Golden State Medical Supply, Inc. 534d78c5-4ba0-4ab1-e063-6294a90a8ff7 2026-08-05 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE ALLERGY RELIEF NASAL FLUTICASONE PROPIONATE Amazon.com Services LLC dc552613-5cfe-4de3-b2c0-79703316758a 2026-07-30 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE The Kroger Co. f05689fa-7ff3-0846-c647-bdbe79cb2ff8 2026-07-29 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE DISKUS FLUTICASONE PROPIONATE Sportpharm LLC 348cbd8c-edeb-499c-961d-3aeb5cc2cef1 2026-07-28 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE P & L Development, LLC e3347976-facd-49b6-9ae1-7ed3cd02ba96 2026-07-02 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate FLUTICASONE PROPIONATE Chain Drug Marketing Association, Inc. 0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc7 2026-07-02 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Childrens Fluticasone Propionate ALLERGY RELIEF FLUTICASONE PROPIONATE GLENMARK THERAPEUTICS INC., USA 9aaa30cf-1e3b-4382-91dc-568067a4b0ac 2026-06-30 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Family Dollar Stores, LLC 4dd65267-9905-4f45-e063-6294a90a2516 2026-06-17 Warnings Name fallback generic name: FLUTICASONE PROPIONATE Fluticasone Propionate ALLERGY RELIEF FLUTICASONE PROPIONATE YYBA CORP 5348075c-63ca-20f7-e063-6394a90a3f5c 2026-06-12 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE Preferred Pharmaceuticals Inc. 8225d521-f1f7-4d21-9095-9a2e1833d1bf 2026-06-08 Warnings, Adverse reactions Name fallback generic name: FLUTICASONE PROPIONATE allergy relief nasal FLUTICASONE PROPIONATE HyVee Inc c3327be1-e4a9-4b02-968d-eff5e18cbc84 2026-06-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE allergy nasal FLUTICASONE PROPIONATE Rite Aid Corporation e471dacd-9b6e-4783-9a14-aa95d00cbc9c 2026-06-03 Warnings Name fallback generic name: FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE YYBA Corp 5333562e-9d8e-2618-e063-6394a90a8673 2026-06-01 Warnings Name 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0434 FLUTICASONE PROPIONATE fluticasone propionate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0168-0434 FLUTICASONE PROPIONATE fluticasone propionate Fougera Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 10337-434 Cutivate fluticasone propionate PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 10337-434 Cutivate fluticasone propionate PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 14511 SUPPL 2015-01-20 4479 SUPPL 2015-01-20 36221 SUPPL 2011-05-16 4480 SUPPL 2011-05-16 4478 SUPPL 2010-09-08 14510 SUPPL 2010-09-07 21479 ORIG 2007-09-10 26913 ORIG 2005-04-06 63518 ORIG 1900-01-01 63010 SUPPL 1900-01-01 51116 SUPPL 1900-01-01 51115 SUPPL 1900-01-01 51113 SUPPL 1900-01-01