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 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
N021152-001	CUTIVATE	FLUTICASONE PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31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 · 43 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
2026-09-14 22:38:34	2026-08	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`caaa826d4ba7…`
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UTC	2026-02	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`011fe1cb6892…`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of this ZIP	2025-12	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`31067a03dcf5…`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UTC	2025-08	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`6a471c1ec25d…`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…`

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 4 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	0cd0b88c-1ab3-4699-8eda-554054b8d33c	2025-10-30	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Encube Ethicals, Inc.	b734d397-e064-4d13-b0b5-fc89bd87f2e3	2025-10-27	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Sam's West, Inc	d2a6e22c-1159-c86a-b927-e7ace1d7023f	2025-10-24	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Hikma Pharmaceuticals USA Inc.	0d9a521b-8314-437c-8c9f-f6188f1134fe	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bryant Ranch Prepack	36c0e343-5bd4-447e-8651-c5f44d2ffd7c	2025-09-24	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Childrens Nasopro	FLUTICASONE PROPIONATE	H E B	607d0a22-72d1-440f-9dac-e088b68dde09	2025-08-11	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICARE	FLUTICASONE PROPIONATE	INNOVUS PHARMACEUTICALS, INC.	fed545ab-6a85-4ce3-8651-370e279db49e	2025-07-16	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0	2025-07-08	Adverse reactions	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walmart	8616944c-a684-085a-7106-cf034e3f6f4d	2025-07-01	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
DG Health childrens allergy relief nasal	FLUTICASONE PROPIONATE	Dolgencorp Inc	4dc4b47a-233c-4bb8-b08b-c07561c415ff	2025-06-03	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
basic care childrens allergy relief nasal	FLUTICASONE PROPIONATE	Amazon.com Services LLC	cb4cb80a-9bc5-4e7b-a33b-fb462abf96c5	2025-05-23	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bi-Mart	3e4ff2eb-0d99-4ce7-910e-81f878b2231e	2025-05-22	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	TWIN MED LLC	9337aa4b-382d-4ab9-b312-60417cdd40cf	2025-05-01	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