Application 088539

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A088539-001	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL			1984-03-21

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`f41ea6bd6efb…`

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 10 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	282ed5ef-8c2a-4092-9d99-1a7eee7a39e3	2025-09-09	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	e90df2e5-2ef4-47dd-bd74-be9cea6d9d85	2025-09-08	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	2025-09-08	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	HYDROCORTISONE	Click Industries LLC	328c389c-7e05-4892-a9b3-b6a753f4935a	2025-08-25	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE SPRAY	FSA Store Inc.	3ce24b87-55ac-0bbd-e063-6294a90ab582	2025-08-19	Warnings	Name fallback brand name: Hydrocortisone
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Name fallback generic name: HYDROCORTISONE
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
Cortizone 10 Cooling	HYDROCORTISONE	Chattem, Inc.	14d9fce2-9f54-4204-83cb-161de8a303f0	2025-08-01	Warnings	Name fallback generic name: HYDROCORTISONE
Rite Aid anti-itch	HYDROCORTISONE	Rite Aid Corporation	2a232dd1-9071-4c55-a7f7-19d8404b99a6	2025-07-28	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	RITE AID CORPORATION	05598255-3e7a-46a5-ae7e-dcfcb616d59d	2025-07-28	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	TARGET Corporation	682b737f-e453-4079-bf31-47a9485c7897	2025-07-25	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	NuCare Pharmaceuticals,Inc.	a0fde5c9-afb2-76a9-e053-2995a90af3e8	2025-07-21	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone anti-itch plus	HYDROCORTISONE	Wal-Mart Stores, Inc.	a0c6e180-b385-4a9b-a9cf-84a551f533d0	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
Itch Relief	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	ae4b7cd6-8b5d-4d25-86f9-72260638bb94	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
Freds Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	FRED'S, INC.	7502eebe-11c5-4e9e-b427-b87180a84349	2025-07-16	Warnings	Name fallback generic name: HYDROCORTISONE
TopCare Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Topco Associates LLC	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	TARGET Corporation	72c3889c-b743-4728-a315-6e4063e00200	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE
Shopko Hydrocortisone Maximum Strength	HYDROCORTISONE	Shopko Stores Operating Co., LLC	0431a6af-4c9a-4bbd-a535-cba31a5e53cc	2025-07-15	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.