Application 210034

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	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
A210034-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		2018-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210034-001	AB1

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	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210034-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	2018-06-15	`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	A210034-001	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210034-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210034-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210034-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210034-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210034-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210034-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210034-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210034-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210034-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210034-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210034-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210034-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210034-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210034-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210034-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210034-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210034-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210034-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210034-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210034-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210034-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210034-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210034-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210034-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210034-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210034-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210034-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210034-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210034-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210034-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210034-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210034-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210034-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210034-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210034-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210034-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210034-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210034-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210034-001	AB1	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	4990e4c7-78b3-4bc8-85d0-6d58f08121ff	2025-11-04	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	9856b731-0676-405d-817c-de385cbd08a3	2025-09-30	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 63629-2332
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	643682ee-39c8-4a0d-b131-f30077e6e20a	2025-09-03	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 63629-2331
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	21a63bc2-a42a-412c-8dd5-17e279f99f27	2025-09-03	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 63629-2329
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	6d14d269-bae6-493a-81ed-83f6a3aa0f4f	2025-09-03	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 63629-2330
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	2556987f-4b0f-8a83-5bf4-095d67a450b4	2025-08-12	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 70700-109
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	52bf5318-2487-4c7b-aa8d-e98f22cc6104	2023-07-27	Adverse reactions	Exact identifier application applno (ANDA): 210034 application number: ANDA210034 ndc (product): 50090-5079

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5079	Clobetasol Propionate	Clobetasol Propionate	A-S Medication Solutions	ANDA	Current
50090-5079	Clobetasol Propionate	Clobetasol Propionate	A-S Medication Solutions	ANDA	Current
50090-5079	Clobetasol Propionate	Clobetasol Propionate	A-S Medication Solutions	ANDA	Current
63629-2329	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2329	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2330	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2330	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2331	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2331	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2332	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
63629-2332	Clobetasol Propionate	Clobetasol Propionate	Bryant Ranch Prepack	ANDA	Current
70700-109	Clobetasol Propionate	Clobetasol Propionate	Xiromed, LLC	ANDA	Current
70700-109	Clobetasol Propionate	Clobetasol Propionate	Xiromed, LLC	ANDA	Current
70700-109	Clobetasol Propionate	Clobetasol Propionate	Xiromed, LLC	ANDA	Current
70700-109	Clobetasol Propionate	Clobetasol Propionate	Xiromed, LLC	ANDA	Current
70700-109	Clobetasol Propionate	Clobetasol Propionate	Xiromed, LLC	ANDA	Current