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 8 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Trifluent Pharma LLC	20508a94-01bc-4f1d-a42b-122a31402aaf	2025-12-01	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	e2df8130-e7c8-4fde-a6d6-c71378991213	2025-12-01	Warnings	Name fallback generic name: HYDROCORTISONE
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	d04e473d-8bbc-475c-a0b1-ca5eed67fbc7	2025-12-01	Warnings	Name fallback generic name: HYDROCORTISONE
Aquanil HC	HYDROCORTISONE	Person and Covey	6b9258e4-c7c4-765e-e053-2991aa0a9f4e	2025-11-29	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Henry Schein	eb031535-d17e-9d5e-e053-2a95a90ad3e0	2025-11-25	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	ANTI-PRURITIC	Cardinal Health	8b3af210-3097-8c10-e053-2a95a90a86f1	2025-11-25	Warnings	Name fallback brand name: Hydrocortisone
Hydrocortisone	ANTI-ITCH	Cardinal Health	884c8227-b4f3-7ef1-e053-2995a90a0ee3	2025-11-25	Warnings	Name fallback brand name: Hydrocortisone
health beyond	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af	2025-11-23	Warnings	Name fallback generic name: HYDROCORTISONE
Absolut Skin Corticosoothe Anti-Itch	HYDROCORTISONE	Absolut Skin Incorporated	deb52218-9176-4aaa-a22f-b66dada6690f	2025-11-19	Warnings	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE
HEALING TREE CALMING ANTI-ITCH	HYDROCORTISONE	Renu Laboratories, LLC	fc8bcde9-26e8-a35f-e053-6394a90a3300	2025-11-06	Warnings	Name fallback generic name: HYDROCORTISONE
Proctosol-HC	HYDROCORTISONE	Bryant Ranch Prepack	68e177fd-87aa-45f3-a380-0d092abdb77d	2025-11-05	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	b6808d2d-192c-4d70-a2e8-bf13375c0280	2025-11-05	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone Anti-Itch	HYDROCORTISONE	Universal Distribution Center LLC	186afb11-06b6-4bfa-e063-6294a90aefc6	2025-10-30	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE SPRAY	Meijer Distribution Inc.	28daaf97-b0b3-7a54-e063-6294a90a23f1	2025-10-30	Warnings	Name fallback brand name: Hydrocortisone
CVS Cools Itch Fast	HYDROCORTISONE	CVS Pharmacy, Inc.	8a4544df-bbba-47d2-ada0-352757abc91f	2025-10-29	Warnings	Name fallback generic name: HYDROCORTISONE
Winco Maximum Strength Hydrocortisone	HYDROCORTISONE	WINCO FOODS, LLC	b1812ea3-78cc-607a-e053-2a95a90a0a10	2025-10-29	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	8c03671d-28ab-4027-8f5f-d342177ce5f2	2025-10-28	Adverse reactions	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE CONTINUOUS SPRAY	Premier Brands of America, Inc.	d344f68b-9b62-3029-e053-2995a90a1665	2025-10-27	Warnings	Name fallback brand name: Hydrocortisone
WinCo Foods Hydrocortisone Cream Intensive Healing	HYDROCORTISONE	WINCO FOODS, LLC	ac4e0e24-9295-b83b-e053-2995a90a996f	2025-10-22	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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