Application 021844

Type: NDA
Sponsor: LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESONATE	DESONIDE	GEL;TOPICAL	0.05%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021844-001	DESONATE	DESONIDE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20

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 · 42 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
2026-08-18 06:07:40	2026-07	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD	2006-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD	2006-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD, RS	2006-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD	2006-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD	2006-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD	2006-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021844-001	DESONATE	0.05%	GEL / TOPICAL	AB	RLD, RS	2006-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021844-001	DESONATE	0.05%	GEL / TOPICAL	AB	RLD, RS	2006-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021844-001	DESONATE	0.05%	GEL / TOPICAL	AB	RLD, RS	2006-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD, RS	2006-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD, RS	2006-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021844-001	DESONATE	0.05%	GEL / TOPICAL		RLD, RS	2006-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021844-001	DESONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	2006-10-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N021844-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021844-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021844-001	AB	1	`c0c555d07b60…`

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	N021844-001	6387383	2020-08-03	U-783	Drug substance, Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021844-001	6387383	2020-08-03	U-783	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021844-001	6387383	2020-08-03	U-783	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021844-001	6387383	2020-08-03	U-783	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021844-001	6387383	2020-08-03	U-783	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021844-001	6387383	2020-08-03	U-783	Drug substance, 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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Sun Pharmaceutical Industries, Inc.	af607c32-3da9-4fbe-99e7-4934a5c8d8f0	2026-07-14	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Inc.	9eade7ae-effc-49b5-af7d-8caa183ff252	2026-04-17	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Bryant Ranch Prepack	0892a9fd-74e6-4a5e-8bc8-9d4146cadb61	2026-04-01	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Bryant Ranch Prepack	c70aabe7-c044-40cd-b17d-35c665160c9c	2026-04-01	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Bryant Ranch Prepack	217e953b-4296-4c5a-ae07-675c96c35249	2026-03-20	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Inc.	c3420815-e9d8-4c19-b601-b918b0aa1f84	2026-02-03	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Inc.	90f27c9b-5c9e-4152-9ddf-659231ca993a	2026-01-23	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Viona Pharmaceuticals Inc	fdeb2a20-a612-4ae5-9178-222295271274	2026-01-12	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Zydus Lifesciences Limited	e381c179-426d-4e4d-9f67-00ac632ac03e	2026-01-12		Name fallback generic name: DESONIDE
Desonide	DESONIDE	Bryant Ranch Prepack	84ceca9d-94af-46a2-be96-601892f2c535	2025-09-08	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Actavis Pharma, Inc.	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	2025-09-08	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Sun Pharmaceutical Industries, Inc.	6cea3912-23ae-45f3-b535-6fea29c7594f	2025-07-02	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Proficient Rx LP	81a8b199-524e-40e4-898a-c485cbf8bc22	2025-05-01	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Limited	99955d05-1198-4cd6-b2b4-9c328e48c0b2	2025-04-11	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Limited	d210d307-72df-40fb-89c9-88663b0e4901	2025-03-26	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Alembic Pharmaceuticals Limited	591762b3-f223-49a1-8e65-63e9086110df	2025-03-07	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Advanced Rx of Tennessee, LLC	0beda157-efd4-5245-e063-6394a90a6911	2024-12-31	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	Advanced Rx of Tennessee, LLC	1d7632a7-0f27-9e5d-e063-6294a90ad21f	2024-07-17	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	NORTHSTAR RX LLC	bec5bd7f-2837-4767-8aa2-582cf58c6d2f	2023-09-14	Adverse reactions	Name fallback generic name: DESONIDE
Desonide	DESONIDE	NORTHSTAR RX LLC	0665dd04-1d0b-45bf-90e4-c6e0bd90956d	2023-07-19	Adverse reactions	Name fallback generic name: DESONIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10922-828	DESONATE	desonide	Intendis Inc.	NDA	Current
50222-504	DESONATE	desonide	LEO Pharma Inc.	NDA	Current
50222-504	DESONATE	desonide	LEO Pharma Inc.	NDA	Current
50419-828	DESONATE	desonide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-828	DESONATE	desonide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
16446	SUPPL	2014-07-24
6287	SUPPL	2014-07-24
16445	SUPPL	2010-01-12
6286	SUPPL	2010-01-05
42324	ORIG	2008-09-05
28697	ORIG	2006-10-23
16444	ORIG	2006-10-23