Application 077770

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOXIMETASONE	DESOXIMETASONE	OINTMENT;TOPICAL	0.25%	No	No

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
A077770-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2015-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077770-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077770-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2015-04-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077770-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077770-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077770-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077770-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077770-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077770-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077770-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077770-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077770-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077770-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077770-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077770-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077770-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077770-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077770-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077770-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077770-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077770-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077770-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077770-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077770-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077770-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077770-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077770-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077770-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077770-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077770-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077770-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077770-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077770-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077770-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077770-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077770-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077770-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077770-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077770-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077770-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077770-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077770-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077770-001	AB	1	`e64feba35796…`

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	Bryant Ranch Prepack	155e0a5f-183b-4517-88e3-22fef48d72c8	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770 ndc (product): 63629-8642
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	2a59a313-efd8-4377-bd41-caeeffa79775	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	dbaa172e-2f78-4c14-9abc-cc171b75115d	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770 ndc (product): 63629-8641
desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4025ed23-a591-4754-8dbb-4da18f49a3e3	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077770 application number: ANDA077770 ndc (product): 45802-496

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-496	desoximetasone	Desoximetasone	Perrigo New York Inc	ANDA	Current
45802-496	desoximetasone	Desoximetasone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-496	desoximetasone	Desoximetasone	Perrigo New York Inc	ANDA	Current
45802-496	desoximetasone	Desoximetasone	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8641	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current
63629-8641	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current
63629-8641	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current
63629-8642	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current
63629-8642	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current
63629-8642	desoximetasone	Desoximetasone	Bryant Ranch Prepack	ANDA	Current