Application 205206

Type: ANDA
Sponsor: ZYDUS PHARMS

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
A205206-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	RS	2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205206-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	RS	2017-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	RS	2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	RS	2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	RS	2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205206-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2017-09-19	`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	A205206-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205206-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205206-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205206-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205206-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205206-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205206-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205206-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205206-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205206-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205206-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205206-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205206-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205206-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205206-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205206-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205206-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205206-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205206-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205206-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205206-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205206-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205206-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205206-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205206-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205206-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205206-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205206-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205206-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205206-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205206-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205206-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205206-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205206-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205206-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205206-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205206-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205206-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205206-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205206-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
desoximetasone	DESOXIMETASONE	Zydus Lifesciences Limited	959e396a-2458-43b5-b412-db1974d58d8d	2024-08-14		Exact identifier application applno (ANDA): 205206 application number: ANDA205206 ndc (product): 70771-1166
desoximetasone	DESOXIMETASONE	Viona Pharmaceuticals Inc	f8e213a9-5e80-45e2-834c-7734dd39c1ac	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205206 application number: ANDA205206 ndc (product): 72578-095

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-889	desoximetasone	desoximetasone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-889	desoximetasone	desoximetasone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-889	desoximetasone	desoximetasone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-889	desoximetasone	desoximetasone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-7695	desoximetasone	desoximetasone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7695	desoximetasone	desoximetasone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70771-1166	desoximetasone	desoximetasone	Cadila Healthcare Limited	ANDA	Current
70771-1166	desoximetasone	desoximetasone	Zydus Lifesciences Limited	ANDA	Current
70771-1166	desoximetasone	desoximetasone	Cadila Healthcare Limited	ANDA	Current
70771-1166	desoximetasone	desoximetasone	Cadila Healthcare Limited	ANDA	Current
72578-095	desoximetasone	desoximetasone	Viona Pharmaceuticals Inc	ANDA	Current
72578-095	desoximetasone	desoximetasone	Viona Pharmaceuticals Inc	ANDA	Current