Application 019958

Type: NDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CUTIVATE	FLUTICASONE PROPIONATE	CREAM;TOPICAL	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019958-001	CUTIVATE	FLUTICASONE PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1990-12-18

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019958-001	CUTIVATE	0.05%	CREAM / TOPICAL	RLD	1990-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019958-001	CUTIVATE	0.05%	CREAM / TOPICAL	RLD	1990-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CREAM / TOPICAL	RLD	1990-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019958-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1990-12-18	`f41ea6bd6efb…`

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 6 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUTICASONE PROPIONATE DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	64d669da-559c-40f5-b649-2ce164c211ea	2024-01-30	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	4a4b7242-1083-4912-a318-25c3914aaf22	2024-01-11	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	A-S Medication Solutions	038e6c40-9421-40ef-874b-8f4d7110a74a	2024-01-11	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	674b1c81-359d-4fc4-8ce6-a53931b171e0	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	74563f7b-8512-4b76-8c55-b88b9cd3206b	2023-12-09	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	16985600-3f81-4d51-8bf7-0cbbd89856a1	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	a4e1c265-5205-4089-8190-0755ede83896	2023-11-28	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	e7ef2aaf-749c-66c9-2bdf-7214ab00060e	2023-11-22	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	A-S Medication Solutions	4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d	2023-11-17	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	8bd6f3a4-87f7-449e-8fcc-fec1537fcab3	2023-07-17	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	0120296b-bebc-4a2d-8058-6caf41f96e52	2023-07-17	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	e2df3810-3b92-4678-8f62-683c656b1de9	2023-04-16	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	78e056e2-d39e-4d20-9ab2-332bd6973619	2022-12-30	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
topcare fluticasone propionate nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	f7c425d2-4afb-478f-83bc-eb336910233b	2022-11-01	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
equate allergy relief	FLUTICASONE PROPIONATE	Wal-Mart Stores Inc	959167e8-f4a1-49b9-b3a6-f0d0b3d7d477	2022-10-14	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	75049554-64ca-4efa-b8d1-13cf31d0ff90	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Cosette Pharmaceuticals, Inc.	14c8d082-b301-8f09-a509-950459ae0a28	2022-05-05	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Glenmark Pharmaceuticals Inc., USA	3c7b3482-e2fd-4857-9394-a47fd7f4c47b	2020-02-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Proficient Rx LP	96af29b8-16b4-4113-9ec3-338438e11a49	2019-11-01	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLOVENT DISKUS	FLUTICASONE PROPIONATE	Proficient Rx LP	816e929e-6ba0-437d-80bb-00068419ed53	2019-11-01	Warnings, Adverse reactions	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10337-332	Cutivate	fluticasone propionate	PharmaDerm a division of Fougera Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19894	SUPPL	2010-09-08
34149	SUPPL	2010-09-07
34148	SUPPL	2002-04-16
1855	SUPPL	2002-04-16
41107	SUPPL	1999-06-17
34147	SUPPL	1999-06-17
34146	SUPPL	1999-06-17
1854	SUPPL	1999-06-17
1853	SUPPL	1999-06-17