Application 211295

Type: ANDA
Sponsor: ENCUBE

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 1.

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
A211295-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211295-001	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
2026-02-19 14:30 UTC	2026-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-11-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211295-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2019-11-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211295-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211295-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211295-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211295-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211295-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211295-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211295-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211295-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211295-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211295-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211295-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211295-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211295-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211295-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211295-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211295-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211295-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211295-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211295-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211295-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211295-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211295-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211295-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211295-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211295-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211295-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211295-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211295-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211295-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211295-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211295-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211295-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211295-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211295-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211295-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211295-001	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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Encube Ethicals, Inc.	1f076779-3f76-47d5-99f0-9b0b2d3f5fac	2026-07-09	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 21922-017
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT, 0.05%	Preferred Pharmaceuticals Inc.	087c5aee-d7fd-42ce-b213-14c810292808	2026-03-30	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 68788-7963
Clobetasol Propionate	CLOBETASOL PROPIONATE USP, 0.05%	A-S Medication Solutions	485e931d-16a7-4e92-996e-d3b32d9f41e7	2025-12-06	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	4d9b83e8-593e-4add-ac1d-c8eea25761bc	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	7c71c9a8-9c76-4de4-982f-42eb54b7689c	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	fa0e3c04-4b45-4aca-8b59-7df2ec3963e7	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	09717dc5-eef3-4f50-a346-f91d7e86fec9	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	60f65ee3-b972-4e58-97fe-0c0ab14b9b48	2025-10-21	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	d6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 63629-2455
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	032f1f4e-1f1c-409a-8fac-6449ee543caa	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 63629-2456
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	3dcc49e7-a4f8-44cf-9405-2786bdc910cb	2025-01-24	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 63629-2457
Clobetasol Propionate	CLOBETASOL PROPIONATE OINTMENT USP, 0.05%	Bryant Ranch Prepack	c57776d2-06d7-4019-95df-ff38f721dec5	2024-04-12	Adverse reactions	Exact identifier application applno (ANDA): 211295 application number: ANDA211295 ndc (product): 63629-2458

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-017	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Encube Ethicals Private Limited	ANDA	Current
21922-017	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Encube Ethicals Private Limited	ANDA	Current
21922-017	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Encube Ethicals Private Limited	ANDA	Current
63629-2455	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2455	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2456	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2456	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2457	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2457	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2458	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
63629-2458	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	Bryant Ranch Prepack	ANDA	Current
68071-2218	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2218	Clobetasol Propionate	Clobetasol Propionate Ointment USP, 0.05%	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7963	Clobetasol Propionate	Clobetasol Propionate Ointment, 0.05%	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7963	Clobetasol Propionate	Clobetasol Propionate Ointment, 0.05%	Preferred Pharmaceuticals Inc.	ANDA	Current