Home Applications 040417 Application 040417
Type ANDA
Sponsor LANNETT CO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE LOTION;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 A040417-001 HYDROCORTISONE HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30
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 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 2003-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040417-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2003-07-30 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 12 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 Warnings Name fallback generic name: HYDROCORTISONE Proctosol-HC HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 565284e7-4994-486b-8267-18bd166655ac 2025-07-02 Adverse reactions Name fallback generic name: HYDROCORTISONE Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Name fallback generic name: HYDROCORTISONE MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Name fallback generic name: HYDROCORTISONE Post-Treatment Repair Cream HYDROCORTISONE Vi Medical Products Inc. ab8885a9-0778-28ff-e053-2995a90a2e12 2025-06-19 Warnings Name fallback generic name: HYDROCORTISONE ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37cdfabc-1fdb-246a-e063-6394a90a008a 2025-06-17 Warnings Name fallback generic name: HYDROCORTISONE ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37ce6c35-b211-43de-e063-6294a90ab773 2025-06-17 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. f7aecfb4-c194-4554-8d05-4e46005e654b 2025-05-27 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA d57a59fb-c8f2-f73b-e053-2995a90a4cdb 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 4c96ec41-841c-322b-e054-00144ff8d46c 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE ANI Pharmaceuticals, Inc. 0d7e8e04-9149-4436-bad1-b700e253b7ab 2025-05-05 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE DermaCort Anti-itch HYDROCORTISONE Melaleuca, Inc. 24044b0f-dd1e-4762-82b8-7a28b08c2f77 2025-03-20 Warnings Name fallback generic name: HYDROCORTISONE Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Name fallback 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-5132 Hydrocortisone Hydrocortisone Lannett Company, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42624 ORIG 2005-07-15