Application 075666

Type: ANDA
Sponsor: PERRIGO ISRAEL

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
A075666-001	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL			2000-05-24

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	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL		2000-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075666-001	HYDROCORTISONE VALERATE	0.2%	CREAM / TOPICAL	AB	2000-05-24	`e64feba35796…`

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	A075666-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075666-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075666-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075666-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075666-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075666-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075666-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075666-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075666-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075666-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075666-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075666-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075666-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075666-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075666-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075666-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075666-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075666-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075666-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075666-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075666-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075666-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075666-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075666-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075666-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075666-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075666-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075666-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075666-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075666-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075666-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075666-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075666-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075666-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075666-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075666-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075666-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075666-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075666-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075666-001	AB	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	Lupin Pharmaceuticals, Inc.	17e93b8c-aede-4cab-9a8c-0c29abdb05f2	2025-11-13	Adverse reactions	Name fallback brand name: HYDROCORTISONE VALERATE generic name: HYDROCORTISONE VALERATE
Hydrocortisone Valerate	HYDROCORTISONE VALERATE	Sun Pharmaceutical Industries, Inc.	a9011d6f-6808-48a7-ab6b-df8d40540570	2025-07-07	Adverse reactions	Name fallback brand name: Hydrocortisone Valerate generic name: HYDROCORTISONE VALERATE
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	Cosette Pharmaceuticals, Inc.	fd68f7a2-fa0d-4d56-8e92-71cd955cc7a9	2023-11-29	Adverse reactions	Name fallback brand name: HYDROCORTISONE VALERATE generic name: HYDROCORTISONE VALERATE
Hydrocortisone Valerate	HYDROCORTISONE VALERATE	Cosette Pharmaceuticals, Inc.	1cb06573-1ac8-4dfe-8123-00bbd20a1650	2023-11-29	Adverse reactions	Name fallback brand name: Hydrocortisone Valerate generic name: HYDROCORTISONE VALERATE
Hydrocortisone Valerate	HYDROCORTISONE VALERATE	Glenmark Pharmaceuticals Inc., USA	18db91a0-fe67-4740-8a37-d656707356f1	2019-03-05	Adverse reactions	Name fallback brand name: Hydrocortisone Valerate generic name: HYDROCORTISONE VALERATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-455	Hydrocortisone Valerate	Hydrocortisone Valerate	Perrigo New York Inc	ANDA	Current
45802-455	Hydrocortisone Valerate	Hydrocortisone Valerate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-455	Hydrocortisone Valerate	Hydrocortisone Valerate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-2525	Hydrocortisone Valerate	Hydrocortisone Valerate	A-S Medication Solutions	ANDA	Current
61919-010	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	DIRECT RX	ANDA	Current
61919-010	HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30983	ORIG	2000-05-24