Application 076510

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOXIMETASONE	DESOXIMETASONE	CREAM;TOPICAL	0.25%	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
A076510-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB		2003-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076510-001	AB

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	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076510-001	DESOXIMETASONE	0.25%	CREAM / TOPICAL	AB	2003-07-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076510-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076510-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076510-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076510-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076510-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076510-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076510-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076510-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076510-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076510-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076510-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076510-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076510-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076510-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076510-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076510-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076510-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076510-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076510-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076510-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076510-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076510-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076510-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076510-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076510-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076510-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076510-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076510-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076510-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076510-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076510-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076510-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076510-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076510-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076510-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076510-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076510-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076510-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076510-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076510-001	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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desoximetasone	DESOXIMETASONE	A-S Medication Solutions	54743c9d-badd-47ce-bf86-6a8c398f7f07	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510 ndc (product): 50090-0597
Desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	302fc53a-2779-4168-b76c-9ae0cf0b3331	2025-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510
Desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4ad6c159-4daa-4a33-8db6-351b5263323d	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510 ndc (product): 45802-495
Desoximetasone	DESOXIMETASONE	Proficient Rx LP	4f90b0cd-9443-4940-8781-1a05e42ccbb8	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076510 application number: ANDA076510 ndc (product): 63187-646

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-495	Desoximetasone	Desoximetasone	Perrigo New York Inc	ANDA	Current
45802-495	Desoximetasone	Desoximetasone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-0597	Desoximetasone	Desoximetasone	A-S Medication Solutions	ANDA	Current
63187-646	Desoximetasone	Desoximetasone	Proficient Rx LP	ANDA	Current
63187-646	Desoximetasone	Desoximetasone	Proficient Rx LP	ANDA	Current
63187-646	Desoximetasone	Desoximetasone	Proficient Rx LP	ANDA	Current