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 3 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Scalpicin Anti-Itch Maximum Strength HYDROCORTISONE Reckitt Benckiser LLC 7b1a29fa-b266-43e6-a87b-aa3c96ab4041 2026-05-13 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 02ab1006-c7c8-42c9-bda8-62c9d7142521 2026-05-11 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals, Inc. 058bb2ff-ff51-4a3b-ba47-cb02272d0631 2026-05-11 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals Inc. 12cd35e3-e707-4551-b778-bf615c1a8d32 2026-05-11 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Preferred Pharmaceuticals Inc. 0bbb8a63-ae1d-41d7-b201-d1b171b31f46 2026-05-11 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Preferred Pharmaceuticals, Inc. 026728d4-846b-4bd4-9183-ae6c4a714138 2026-05-11 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Harris Teeter Hydrocortisone HYDROCORTISONE HARRIS TEETER LLC 4e8199f8-96ec-5342-e063-6294a90afb2d 2026-05-07 Warnings Name fallback generic name: HYDROCORTISONE CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 5114cdba-96a1-c399-e063-6294a90aac12 2026-05-06 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 2026-04-29 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE anti itch HYDROCORTISONE HyVee Inc e1db3641-2e83-4fec-8394-98d0d876ce0d 2026-04-29 Warnings Name fallback generic name: HYDROCORTISONE FixMySkin Healing Balm Vanilla Flavor HYDROCORTISONE Lovely Skin, Inc. 52f7a561-a0b5-4562-a588-d74fd874b83a 2026-04-28 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sportpharm LLC ef9cf62a-5805-48bc-915e-c0e91a10837e 2026-04-24 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sportpharm LLC 78f43570-b6fd-42eb-bb9e-580abf79bf0d 2026-04-24 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE FixMySkin Healing Balm Unflavored HYDROCORTISONE Lovely Skin, Inc. 9ff8db07-ad6d-4865-a534-94bd8312957e 2026-04-23 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack c3916e9f-f783-45a2-b38b-959b12c26252 2026-04-22 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone 1% HYDROCORTISONE Preferred Pharmaceuticals Inc. e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4 2026-04-22 Warnings Name fallback generic name: HYDROCORTISONE Alkindi Sprinkle HYDROCORTISONE Eton Pharmaceuticals, Inc. 26c13a5f-7119-4c6a-bf10-fda4e07d7682 2026-04-21 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Anti-Itch Regular Strength HYDROCORTISONE CVS Pharmacy 9fe7768b-9023-c9ee-e053-2a95a90a55b3 2026-04-17 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE CREAM HART Health c76fb030-cbb5-4773-aa52-d038cb41d0af 2026-04-15 Warnings Name fallback brand name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 2352bb58-a624-4c5e-8966-f68817c30470 2026-04-03 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 · 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