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 16 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	9e663535-4acc-4b37-acae-8c17517c5a3d	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	849c60fc-e455-4c50-8adf-ac59c0ee785b	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
rexall anti itch maximum strength relief	HYDROCORTISONE	Dolgencorp, LLC	894cf9ab-693a-4210-96df-605947f51b63	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	070000d7-7d4d-439b-9a91-851ba7c027e6	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone anti itch	HYDROCORTISONE	H E B	a1a9fed8-4938-48b5-81f1-d3942d534bb8	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	ef9ea069-9b97-4bf5-aaac-deb85334dbd0	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
Basic Care Hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	7fa13ab4-5f2d-4a48-816f-1b22d5f757b2	2024-10-03	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	dc388dc1-0c4f-4bf1-8a12-fa39892317bc	2024-10-02	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
RUGBY HYDROCORTISONE WITH ALOE	HYDROCORTISONE	A-S Medication Solutions	b2674075-aaa4-4c77-bcaa-a76336b3c321	2024-10-02	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	A-S Medication Solutions	5d7ae83f-e9ad-4805-812c-919065cb69af	2024-10-02	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Herb Street Anti-Itch Stick	HYDROCORTISONE	Balassa Laboratories Inc.	8717faae-59c3-4c6f-9ef1-285c0d2445ed	2024-10-01	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Name fallback generic name: HYDROCORTISONE
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Name fallback generic name: HYDROCORTISONE
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Name fallback generic name: HYDROCORTISONE
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

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