Home Applications 040351 Application 040351
Type ANDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE LOTION;TOPICAL 2.5% No Yes
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 A040351-001 HYDROCORTISONE HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25
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 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT RS 2000-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT RS 2000-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT RS 2000-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT RS 2000-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040351-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 2000-07-25 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 9 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gelmicin Hydrocortisone with Aloe HYDROCORTISONE United Exchange Corp. bb64eca4-799d-4711-e053-2995a90af403 2025-10-21 Warnings Name fallback generic name: HYDROCORTISONE Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. 8e4d46d8-7084-0666-e053-2995a90ad520 2025-10-21 Warnings Name fallback generic name: HYDROCORTISONE Quadrydern HYDROCORTISONE Productos Zapotol Corp a087ad4d-9a65-19c3-e053-2995a90ab341 2025-10-21 Warnings Name fallback generic name: HYDROCORTISONE Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. deb09e89-9794-89a7-e053-2a95a90abdf8 2025-10-20 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Intensive Healing HYDROCORTISONE Chattem, Inc. bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c 2025-10-20 Warnings Name fallback generic name: HYDROCORTISONE Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Name fallback generic name: HYDROCORTISONE Vanicream HC Anti-Itch HYDROCORTISONE Pharmaceutical Specialties, Inc. 28b06507-27a5-2cb1-e054-00144ff8d46c 2025-10-14 Warnings Name fallback generic name: HYDROCORTISONE Anti-itch HYDROCORTISONE Medline Industries, LP b0947381-c0db-4253-ab40-3d45603ae65d 2025-10-09 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE CVS PHARMACY, INC b3bdff5e-37fe-442a-a370-7b19799ea781 2025-10-07 Warnings Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Bryant Ranch Prepack dc220e63-f9b2-47ea-b8ed-940902a130bf 2025-10-03 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. e4f22e9c-cf38-473a-8f7d-8da7fd696f76 2025-10-02 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Viaderma Calm Anti-Itch HYDROCORTISONE ViaDerma Distribution, Inc. 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e 2025-10-01 Warnings Name fallback generic name: HYDROCORTISONE LEADER HYDROCORTISONE WITH ALOE HYDROCORTISONE LEADER 39916470-15bf-4bd0-96e2-b909d68cf9c4 2025-09-29 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% HYDROCORTISONE Chain Drug Marketing Association Inc. 3d48a3c6-b7d6-6794-e063-6294a90afff9 2025-09-29 Warnings Name fallback generic name: HYDROCORTISONE Xpect Hydrocortisone HYDROCORTISONE Cintas Corporation 45ef9be4-54c4-4d85-966b-27708313ded4 2025-09-26 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Walgreens Company 0b4053a8-6c1c-621d-e063-6394a90a4f56 2025-09-25 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Unishield 1% HYDROCORTISONE Unishield 4871a67f-fbb8-4a6b-ace4-d34349028908 2025-09-24 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 0d85f349-2dc7-44a5-b5bd-83ac78d44d1d 2025-09-24 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE Major Pharmaceuticals 91885fc8-876f-4a4d-8ae5-eb246a335808 2025-09-10 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE 1% Encube Ethicals, Inc. d6f5c0df-6262-4704-bb24-430f66bb2ca8 2025-09-09 Warnings Name fallback brand 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0288 Hydrocortisone hydrocortisone E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0288 Hydrocortisone hydrocortisone E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 7632 ORIG 2000-07-25