Home Applications 040503 Application 040503
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 2.5% 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 A040503-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12
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 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 2004-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040503-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 2004-03-12 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 6 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Hydrocortisone DRS. HYDROCORTISONE OL PHARMA TECH,LLC b0eac8f3-bb80-6563-e053-2995a90a83c9 2026-01-22 Warnings Name fallback brand 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 Hydrocortisone COOL RELIEF GEL WITH ALOE Walgreens 1ae2b37d-d5b2-74d2-e063-6294a90a0de0 2026-01-14 Warnings Name fallback brand 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 brand name: hydrocortisone 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 brand name: Hydrocortisone generic name: HYDROCORTISONE Alacort HYDROCORTISONE Crown Laboratories de000081-a245-4f6b-9e7c-e47d84b82338 2026-01-12 Adverse reactions Name fallback generic name: HYDROCORTISONE Texacort HYDROCORTISONE Mission Pharmacal Company 25279d46-6bad-471f-8bd6-736d53cfd942 2026-01-08 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Strides Pharma Inc. c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6 2026-01-08 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-7781 Hydrocortisone hydrocortisone Lannett Company, Inc. ANDA Current 0603-7781 Hydrocortisone hydrocortisone Par Pharmaceutical ANDA Current 0603-7781 Hydrocortisone hydrocortisone Par Pharmaceutical ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22148 ORIG 2007-07-06