Application 210198

Type: ANDA
Sponsor: CADILA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESONIDE	DESONIDE	CREAM;TOPICAL	0.05%	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
A210198-001	DESONIDE	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210198-001	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.

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	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB		2019-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210198-001	DESONIDE	0.05%	CREAM / TOPICAL	AB	RS	2019-11-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210198-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210198-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210198-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210198-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210198-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210198-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210198-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210198-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210198-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210198-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210198-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210198-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210198-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210198-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210198-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210198-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210198-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210198-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210198-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210198-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210198-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210198-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210198-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210198-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210198-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210198-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210198-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210198-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210198-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210198-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210198-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210198-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210198-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210198-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210198-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210198-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210198-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210198-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210198-001	AB	1	`a50c72e98297…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Bryant Ranch Prepack	0892a9fd-74e6-4a5e-8bc8-9d4146cadb61	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198 ndc (product): 63629-2507
Desonide	DESONIDE	Bryant Ranch Prepack	c70aabe7-c044-40cd-b17d-35c665160c9c	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198 ndc (product): 63629-2506
Desonide	DESONIDE	Bryant Ranch Prepack	217e953b-4296-4c5a-ae07-675c96c35249	2026-03-20	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198
Desonide	DESONIDE	Viona Pharmaceuticals Inc	fdeb2a20-a612-4ae5-9178-222295271274	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198 ndc (product): 72578-086
Desonide	DESONIDE	Zydus Lifesciences Limited	e381c179-426d-4e4d-9f67-00ac632ac03e	2026-01-12		Exact identifier application applno (ANDA): 210198 application number: ANDA210198 ndc (product): 70771-1381
Desonide	DESONIDE	Advanced Rx of Tennessee, LLC	0beda157-efd4-5245-e063-6394a90a6911	2024-12-31	Adverse reactions	Exact identifier application applno (ANDA): 210198 application number: ANDA210198

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
63629-2506	Desonide	Desonide	Bryant Ranch Prepack	ANDA	Current
63629-2506	Desonide	Desonide	Bryant Ranch Prepack	ANDA	Current
63629-2507	Desonide	Desonide	Bryant Ranch Prepack	ANDA	Current
63629-2507	Desonide	Desonide	Bryant Ranch Prepack	ANDA	Current
70710-1235	Desonide	Desonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1235	Desonide	Desonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1235	Desonide	Desonide	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1381	Desonide	Desonide	Zydus Lifesciences Limited	ANDA	Current
70771-1381	Desonide	Desonide	Cadila Healthcare Limited	ANDA	Current
70771-1381	Desonide	Desonide	Cadila Healthcare Limited	ANDA	Current
72578-086	Desonide	Desonide	Viona Pharmaceuticals Inc	ANDA	Current
72578-086	Desonide	Desonide	Viona Pharmaceuticals Inc	ANDA	Current