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 6 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rapidol	HYDROCORTISONE	Pharmadel LLC	19a1f1e2-bc6b-7153-e063-6294a90ab115	2026-01-23	Warnings	Name fallback generic name: HYDROCORTISONE
Aveeno 1% Hydrocortisone Anti-Itch Cream	HYDROCORTISONE	Kenvue Brands LLC	1ac0ac4e-af76-9a3e-e063-6394a90a1269	2026-01-22	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	DRS. HYDROCORTISONE	OL PHARMA TECH,LLC	b0eac8f3-bb80-6563-e053-2995a90a83c9	2026-01-22	Warnings	Name fallback brand name: Hydrocortisone
Anti Itch	HYDROCORTISONE	HyVee Inc	ae31f1f5-db70-45cf-850e-67bfe6860748	2026-01-21	Warnings	Name fallback generic name: HYDROCORTISONE
Skin Relief Cream	HYDROCORTISONE	Spa de Soleil	0a90b77a-4be4-71c5-e063-6294a90a8e41	2026-01-20	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone-10 Soothing Aloe Creme	HYDROCORTISONE	Chattem, Inc.	1a841bf0-9d7b-4566-b442-aa9bcc827846	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisone 10 Sensitive Skin Creme	HYDROCORTISONE	Chattem, Inc.	b139917c-00bb-4cb3-995d-a6d2f2c295c6	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	COOL RELIEF GEL WITH ALOE	Walgreens	1ae2b37d-d5b2-74d2-e063-6294a90a0de0	2026-01-14	Warnings	Name fallback brand name: Hydrocortisone
Cortisone 10 Intensive Moisture Creme	HYDROCORTISONE	Chattem, Inc.	096a9af3-7e7c-4dae-bc22-44061c60d3c9	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Easy Relief	HYDROCORTISONE	Chattem, Inc.	beb73818-cd88-44ff-8ecd-b02b910b53b7	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Feminine Itch Relief	HYDROCORTISONE	Chattem, Inc.	c0c0c1fb-43c9-4903-bb3b-f0885619b8cc	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Ultra Soothing Creme	HYDROCORTISONE	Chattem, Inc.	4b62615f-e713-42f2-8b9c-9eebf8d1b270	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortizone 10 Fast Acting Itch Relief Cooling	HYDROCORTISONE	Chattem, Inc.	01cd77e3-380f-4487-ae6e-3ac45355d8a4	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	0174411c-1b10-4298-b820-87b24065b118	2026-01-14	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
Cortizone 10 Intensive Healing for Eczema	HYDROCORTISONE	Chattem, Inc.	31dc0f1f-ddd8-41dc-b669-b24655634d55	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Cortisone 10 Overnight Creme	HYDROCORTISONE	Chattem, Inc.	ef2eda7e-d6a8-47e3-9d80-6074af6773dc	2026-01-14	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Crown Laboratories	a84830ad-73dc-4a2e-b987-0a1103526535	2026-01-12	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Alacort	HYDROCORTISONE	Crown Laboratories	de000081-a245-4f6b-9e7c-e47d84b82338	2026-01-12	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Texacort	HYDROCORTISONE	Mission Pharmacal Company	25279d46-6bad-471f-8bd6-736d53cfd942	2026-01-08	Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Strides Pharma Inc.	c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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