Application 209701

Type: ANDA
Sponsor: XIROMED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	OINTMENT;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
A209701-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209701-001	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	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209701-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2018-04-17	`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	A209701-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209701-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209701-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209701-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209701-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209701-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209701-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209701-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209701-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209701-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209701-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209701-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209701-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209701-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209701-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209701-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209701-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209701-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209701-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209701-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209701-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209701-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209701-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209701-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209701-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209701-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209701-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209701-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209701-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209701-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209701-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209701-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209701-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209701-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209701-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209701-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209701-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209701-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209701-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209701-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	AvKARE	a862de41-1500-9136-e053-2a95a90a6080	2023-07-03	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701 ndc (product): 42291-077
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	f8e06ea9-bd18-48db-9f53-8e75734c8f01	2023-03-27	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701
Clobetasol Propionate	CLOBETASOL PROPIONATE	Xiromed, LLC	56e6d233-d9ee-f022-3be7-d100799a561e	2020-11-06	Adverse reactions	Exact identifier application applno (ANDA): 209701 application number: ANDA209701 ndc (product): 70700-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-077	Clobetasol Propionate	clobetasol propionate	AvKARE	ANDA	Current
42291-077	Clobetasol Propionate	clobetasol propionate	AvKARE	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current
70700-106	Clobetasol Propionate	clobetasol propionate	Xiromed, LLC	ANDA	Current