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N021152-001	CUTIVATE	FLUTICASONE PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31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N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`84e616aacf4f…`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N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`caaa826d4ba7…`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UTC	2026-02	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`011fe1cb6892…`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of this ZIP	2025-12	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`31067a03dcf5…`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UTC	2025-08	N021152-001	CUTIVATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2005-03-31	`6a471c1ec25d…`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 7 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Fluticasone Propionate	FLUTICASONE PROPIONATE	Selder, S.A. de C.V.	2da4ba91-c356-473d-b20c-5bb9265767df	2017-11-29	Warnings	Name fallback generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4e1cd546-4598-115b-0357-5d0c22731faa	2017-11-17	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