Application 077552

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOXIMETASONE	DESOXIMETASONE	GEL;TOPICAL	0.05%	No	No

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
A077552-001	DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL / TOPICAL			2006-01-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077552-001	DESOXIMETASONE	0.05%	GEL / TOPICAL	AB	2006-01-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077552-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077552-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077552-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077552-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077552-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077552-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077552-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077552-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077552-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077552-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077552-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077552-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077552-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077552-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077552-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077552-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077552-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077552-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077552-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077552-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077552-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077552-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077552-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077552-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077552-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077552-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077552-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077552-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077552-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077552-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077552-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077552-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077552-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077552-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077552-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077552-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077552-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077552-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077552-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077552-001	AB	1	`cb3db0bc1861…`

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 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desoximetasone	DESOXIMETASONE	Saptalis Pharmaceuticals, LLC.	827aee22-cf48-477c-8791-c74f16da954d	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
DESOXIMETASONE	DESOXIMETASONE	Saptalis Pharmaceuticals, LLC.	c84c7168-3d46-4e05-a25c-3d594ff94268	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: DESOXIMETASONE generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	A-S Medication Solutions	54743c9d-badd-47ce-bf86-6a8c398f7f07	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	fdee36f3-7630-4298-ab7c-f5f8ff7c4c04	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Topicort	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	96dfac6f-540f-4b7d-bcee-7e62088ebc93	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Lupin Pharmaceuticals, Inc.	b53727cf-a57f-443f-8036-3d4bd2737540	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Lupin Pharmaceuticals, Inc.	f53ddb86-bf8a-4bb3-b7ce-387fa78d9066	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Lupin Pharmaceuticals, Inc.	da2a8a3e-f187-4906-8fe3-246cc31de16f	2025-11-24	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Lupin Pharmaceuticals, Inc.	e4b648f4-c65d-44b3-a97a-657730f65322	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
DESOXIMETASONE	DESOXIMETASONE	Lupin Pharmaceuticals, Inc.	65e5f3c5-ef24-4e21-9427-fa0d5c283098	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: DESOXIMETASONE generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	The J. Molner Company LLC	2bbb5200-8355-ba86-e063-6394a90a23b6	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	b046ab97-ba1a-4be6-a238-09670b38b397	2025-07-08	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	627031fc-9b91-4854-b08f-f9fc0c73f1de	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	96898d55-aa50-4281-8c23-ec4738ede394	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	37eb1205-1743-4480-8631-b0bbcaeb8359	2025-07-02	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Topicort	DESOXIMETASONE	Sun Pharmaceutical Industries, Inc.	e417856a-b760-4626-bc34-8e4bc62c026c	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	302fc53a-2779-4168-b76c-9ae0cf0b3331	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4ad6c159-4daa-4a33-8db6-351b5263323d	2025-03-07	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	bd914203-d3bf-4f15-b2e4-715ff80e2a52	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Zydus Lifesciences Limited	b780701b-5572-48bc-a5f4-00248eaddd3b	2024-08-14		Name fallback brand name: desoximetasone generic name: DESOXIMETASONE