Home Applications 084969 Application 084969
Type ANDA
Sponsor PERRIGO NEW YORK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 HYDROCORTISONE HYDROCORTISONE OINTMENT;TOPICAL 0.5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A084969-003 HYDROCORTISONE HYDROCORTISONE 0.5% 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A084969-003 HYDROCORTISONE 0.5% OINTMENT / TOPICAL Approved before 1982 cb3db0bc1861…
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 · 392 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 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 Hydrocortisone HYDROCORTISONE Encube Ethicals, Inc. 11e120e2-a1ca-477c-b474-bcbb72656705 2026-06-26 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Medi-First Hydrocortisone 1 % Anti-Itch Cream HYDROCORTISONE Unifirst First Aid Corporation 49f04e5d-746d-cbe9-e063-6294a90a7e88 2026-06-16 Warnings Name fallback generic name: HYDROCORTISONE Hydroxym HYDROCORTISONE PureTek Corporation febffc84-e65e-e811-e053-6294a90a0ad1 2026-06-15 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% Anti-ItchCream HYDROCORTISONE Acme United Corporation 5425fc2b-4f25-3e64-e063-6394a90aff49 2026-06-13 Warnings Name fallback generic name: HYDROCORTISONE good sense anti itch HYDROCORTISONE Preferred Pharmaceuticals Inc. e51047da-8e17-4dd7-be3c-54820a7485f2 2026-06-09 Warnings Name fallback generic name: HYDROCORTISONE Walgreens Scalp Itch Relief HYDROCORTISONE Walgreens 34952272-1f9e-c642-e063-6394a90ae2bd 2026-05-29 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Mylan Pharmaceuticals Inc. bc751403-94f2-4f9d-b533-cf6186a40ceb 2026-05-25 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 858053a0-d888-4bb9-b94e-503bcf3864cb 2026-05-21 Warnings Name fallback generic name: HYDROCORTISONE