Home Applications 080459 Application 080459
Type ANDA
Sponsor VALEANT PHARM INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELDECORT HYDROCORTISONE CREAM;TOPICAL 1% 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 A080459-001 ELDECORT HYDROCORTISONE 1% CREAM / 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 · 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 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080459-001 ELDECORT 1% CREAM / TOPICAL Approved before 1982 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 5 of 19 · 371 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC bc374fa4-ac8b-408e-9321-8bab97a18770 2026-01-28 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 31fbb576-0e76-471c-83c8-9e0125bc1791 2026-01-28 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC bcd103f3-3dc8-4394-b8fd-8f8ddb721f77 2026-01-28 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone with Aloe HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC 4a113699-1eb7-49b8-8cdf-2ad57db89b81 2026-01-27 Warnings Name fallback generic name: HYDROCORTISONE Viaderma Calm Anti-Itch HYDROCORTISONE VIADERMA DISTRIBUTION INC ea281bde-a7a2-47b6-895a-5dc2924972de 2026-01-27 Warnings Name fallback generic name: HYDROCORTISONE 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 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 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 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 generic name: HYDROCORTISONE