Home Applications 086257 Application 086257
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE OINTMENT;TOPICAL 1% 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 A086257-001 HYDROCORTISONE HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086257-001 HYDROCORTISONE 1% OINTMENT / TOPICAL AT Approved before 1982 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 17 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Signature Care Anti Itch HYDROCORTISONE Safeway ed0eb068-3ce6-423d-a7f8-c3456b7f6040 2024-09-23 Warnings Name fallback generic name: HYDROCORTISONE members mark hydrocortisone HYDROCORTISONE Sam's West Inc 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 2024-09-23 Warnings Name fallback generic name: HYDROCORTISONE anti itch HYDROCORTISONE Meijer, Inc. a07496e0-6fc2-4190-8a01-f513134ffb92 2024-09-23 Warnings Name fallback generic name: HYDROCORTISONE Exchange Select Hydrocortisone HYDROCORTISONE Army & Air Force Exchange Service 1b709db3-7dc1-4756-a8a0-dddda875dc57 2024-09-19 Warnings Name fallback generic name: HYDROCORTISONE anti itch HYDROCORTISONE Meijer, Inc. 00040bfe-001a-484e-bec0-e21e8b27f369 2024-09-17 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 0ae1ba79-3992-4910-b03f-6f9b0f26e300 2024-09-12 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 84c95149-9064-4b4d-a7d0-93dfefca1370 2024-08-22 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE NuCare Pharmaceuticals,Inc. 5bb279c6-d572-43a2-e053-2991aa0a686e 2024-08-14 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. fbbbcc67-b46d-d41a-e053-6294a90aa55d 2024-08-08 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack e64cae82-fd7b-47c8-ada9-4dcb283f1d1f 2024-08-07 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE CVS Health Hydrocortisone Anti Itch HYDROCORTISONE CVS Health 546a1b8a-8254-432a-85c4-38ebee5ad568 2024-08-07 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Proficient Rx LP e1166b3a-a304-4030-ab51-eb55c6e91afd 2024-08-01 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 2dda4f32-e0f6-4e8d-8d75-10da5b762790 2024-07-22 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Bryant Ranch Prepack 47bfae62-bf25-413e-93fc-3c72c901f1a5 2024-07-18 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE NuCare Pharmaceuticals,Inc. ac3947c9-5a66-b4e7-e053-2995a90a6f67 2024-07-17 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Bryant Ranch Prepack 6c676166-2471-478c-b662-f8c9c168977b 2024-07-17 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Bryant Ranch Prepack 134fae59-f928-4304-86ca-2271b593caf4 2024-07-15 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Amneal Pharmaceuticals of New York LLC 9fe627ad-4aba-4bd1-8590-6cc2d61674ba 2024-07-03 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.