Application 211047

Type: ANDA
Sponsor: ENCUBE ETHICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	CREAM;TOPICAL	0.2%	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
A211047-001	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB		2021-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211047-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211047-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2021-11-04	`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	A211047-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211047-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211047-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211047-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211047-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211047-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211047-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211047-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211047-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211047-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211047-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211047-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211047-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211047-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211047-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211047-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211047-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211047-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211047-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211047-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211047-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211047-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211047-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211047-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211047-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211047-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211047-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211047-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211047-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211047-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211047-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211047-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211047-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211047-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrocortisone valerate cream	HYDROCORTISONE VALERATE CREAM	Bryant Ranch Prepack	ec57efea-4c46-4207-9dd1-8b27bd96aaa6	2026-01-22	Adverse reactions	Exact identifier application applno (ANDA): 211047 application number: ANDA211047
hydrocortisone valerate cream	HYDROCORTISONE VALERATE CREAM	Bryant Ranch Prepack	544dd7ac-ee59-418b-b3ef-10d682b582c4	2025-10-22	Adverse reactions	Exact identifier application applno (ANDA): 211047 application number: ANDA211047
hydrocortisone valerate cream	HYDROCORTISONE VALERATE CREAM	Encube Ethicals, Inc.	41723504-b2cf-4074-9c3a-e3c59bb48c98	2025-09-09	Adverse reactions	Exact identifier application applno (ANDA): 211047 application number: ANDA211047 ndc (product): 21922-007
hydrocortisone valerate cream	HYDROCORTISONE VALERATE CREAM	Bryant Ranch Prepack	a75dddb5-3acb-4fbb-b6f2-9ba7733127e3	2025-07-29	Adverse reactions	Exact identifier application applno (ANDA): 211047 application number: ANDA211047

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-007	hydrocortisone valerate cream	hydrocortisone valerate cream	Encube Ethicals Private Limited	ANDA	Current
21922-007	hydrocortisone valerate cream	hydrocortisone valerate cream	Encube Ethicals Private Limited	ANDA	Current
21922-007	hydrocortisone valerate cream	hydrocortisone valerate cream	Encube Ethicals Private Limited	ANDA	Current
21922-007	hydrocortisone valerate cream	hydrocortisone valerate cream	Encube Ethicals Private Limited	ANDA	Current