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 1.

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N021152-001	CUTIVATE	FLUTICASONE PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL		RLD	2005-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL		RLD	2005-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL	AB	RLD, RS	2005-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL		RLD	2005-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL		RLD	2005-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021152-001	CUTIVATE	0.05%	LOTION / TOPICAL		RLD	2005-03-31	`3a93d1ddd44b…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N021152-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021152-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021152-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021152-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021152-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021152-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021152-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021152-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021152-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021152-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021152-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	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 3 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Advagen Pharma Ltd	2c1c465c-d008-470e-aa48-8b44bd60751c	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	REMEDYREPACK INC.	d781dd49-ed8d-4204-99ac-a3b632d7640a	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
365 WHOLE FOODS MARKET FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Whole Foods Market, Inc.	313517bd-cb08-49a5-8ef1-e5522cc21c80	2026-01-22	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
leader fluticasone propionate	FLUTICASONE PROPIONATE	Cardinal Health 110, LLC. dba Leader	14bb5d74-0384-417e-a06b-8868d85234dd	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
DG Health Allergy Relief Nasal	FLUTICASONE PROPIONATE	Dolgencorp Inc	5f0514bd-7893-4602-a17b-716fb9947572	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Foster and Thrive Allergy Relief	FLUTICASONE PROPIONATE	Strategic Sourcing Services LLC	67899c15-e5e5-4fe6-a639-71832969a761	2026-01-21	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFA	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals Inc.	ff1cf174-ae6f-45f0-a081-26a34e55f9ea	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	REMEDYREPACK INC.	3c7e3ae6-a78f-4023-a2d4-543615ae25b0	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals, Inc.	4849c4e5-58ea-972c-e063-6394a90a809c	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
XHANCE	FLUTICASONE PROPIONATE	OptiNose US, Inc.	c79bbb9f-e483-4093-8c92-ea978e7bf278	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
allergy relief nasal	FLUTICASONE PROPIONATE	Publix Super Markets Inc	a70e26c8-2f50-49ac-8278-fc06e4c63e6a	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	Rugby Laboratories	5227df05-f2c2-4bc4-91ee-da0fd03d1095	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
good neighbor pharmacy fluticasone propionate	FLUTICASONE PROPIONATE	Amerisource Bergen	b12ddc59-b689-48ac-9a40-2b9ae04a1312	2026-01-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Kirkland Signature Aller Flo	FLUTICASONE PROPIONATE	Costco Wholesale Company	bf120a48-cc29-4f40-b70d-415868ac9d3e	2026-01-06	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Allergy Relief	FLUTICASONE PROPIONATE	Meijer Distribution Inc	b69241d8-f019-43fe-b12b-25edcf01df40	2025-12-12	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
CHILDRENS FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Aurohealth LLC	180ef101-dca6-496f-8376-63449d82d083	2025-12-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	Aurohealth LLC	044a06a1-74fc-43ff-b136-37ad41220941	2025-12-08	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
basic care allergy relief nasal	FLUTICASONE PROPIONATE	Amazon.com Services LLC	6e0628f6-bfdc-4c9d-8800-ffcdb93459f1	2025-11-25	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Golden State Medical Supply, Inc.	db857d81-4b1e-42b8-972a-5bb8735d60f8	2025-11-24	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Equaline Fluticasone Propionate	FLUTICASONE PROPIONATE	United Natural Foods, Inc. dba UNFI	dbaa5264-bbc9-411c-89bb-4aef3ee96459	2025-11-16	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE

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