Home Applications 088539 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 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 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-09-29 23:25 UTC 2022-09 A088539-001 HYDROCORTISONE 10MG TABLET / ORAL 1984-03-21 e64feba35796…
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 20 · 394 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JJ Care HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. c88fa151-f8a8-4de2-98c9-71319bf53e36 2026-08-13 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Safetec of America, Inc. da2b3b2c-11e0-401b-bbd2-d019271d1b3d 2026-08-13 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone with Aloe HYDROCORTISONE TARGET Corporation 4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5 2026-08-11 Warnings Name fallback generic name: HYDROCORTISONE Instant Cooling Itch Relief HYDROCORTISONE CVS Pharmacy 46545d04-5958-d136-e063-6394a90a3462 2026-08-07 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 2026-08-04 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE REMEDYREPACK INC. f0e66726-946b-4f63-b457-2851dc69e6b4 2026-08-03 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Cortizone 10 Itch Relief Massaging Rollerball HYDROCORTISONE Chattem, Inc. 1e27682c-f856-41f1-9935-37540960a4c7 2026-07-31 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Eywa Pharma Inc b3f06d10-2f01-428c-88a4-505c61c87ce8 2026-07-25 Warnings, Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE AEROSOOTHE HYDROCORTISONE Aero Healthcare US LLC 22b172a2-07e8-4ebb-b0a0-dfe4f25477fa 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5763b4de-06f2-7b19-e063-6294a90ad068 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE AKRON PHARMA INC daad9a1e-98d2-4ce7-9d97-ac5d81905abb 2026-07-22 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE LYEON Anti-itch Cream HYDROCORTISONE Guangzhou Xinhongda Trading Service Co., Ltd. 56b773ce-167f-7873-e063-6394a90a9816 2026-07-16 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5698207f-9223-f3a6-e063-6294a90a8ab6 2026-07-14 Warnings Name fallback generic name: HYDROCORTISONE Quadriderm NF HYDROCORTISONE OPMX LLC 5643f850-e0d4-d8d8-e063-6294a90a4260 2026-07-10 Warnings Name fallback generic name: HYDROCORTISONE Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE LOTION Allegis Holdings LLC 1a27d8fa-4025-ed68-e063-6394a90a4f37 2026-07-08 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone Ala-Scalp HYDROCORTISONE Derm Ventures LLC 61498a40-3b3c-4066-89c8-d99686e2d638 2026-07-08 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE DIPROSPAN HYDROCORTISONE OPMX LLC 55fa9ecb-b843-5748-e063-6294a90a2d53 2026-07-06 Warnings Name fallback generic name: HYDROCORTISONE CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Name fallback generic name: HYDROCORTISONE