Home Applications 040247 Application 040247
Type ANDA
Sponsor TARO 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 A040247-001 HYDROCORTISONE HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23
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 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL 1999-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040247-001 HYDROCORTISONE 2.5% LOTION / TOPICAL AT 1999-07-23 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 20 of 20 · 389 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anusol HC HYDROCORTISONE Salix Pharmaceuticals, Inc 5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7 2023-06-01 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Asclemed USA, Inc. 459a9907-1261-4a75-8388-f0e2f466939c 2022-10-12 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Proficient Rx LP d50240db-f630-4008-a272-55ba5c991304 2022-07-01 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Asclemed USA, Inc. b8437441-a4a6-4fb5-82eb-e49af69704f4 2021-04-10 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Actavis Pharma, Inc. aa9dba84-eb38-4ec3-8555-87c948bf2384 2020-07-01 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Aloe Cort HYDROCORTISONE Topiderm, Inc. 789a6669-3320-4558-8d6f-ab255db50d8d 2019-09-17 Warnings Name fallback generic name: HYDROCORTISONE Discount Drug Mart Anti-itch HYDROCORTISONE DISCOUNT DRUG MART, INC. 853eee29-6f57-59d4-e053-2991aa0aa611 2019-03-29 Warnings Name fallback generic name: HYDROCORTISONE Cortisol Phenolic HYDROCORTISONE Energique, Inc. 43d65eee-f4c3-4a6a-a3bb-cfa6d672bc47 2018-09-13 Warnings Name fallback generic name: HYDROCORTISONE Intensive Healing Eczema HYDROCORTISONE Walgreens 3d27f041-c554-4139-87b5-709537785f22 2018-02-04 Warnings Name fallback generic name: HYDROCORTISONE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 7588 ORIG 1999-07-23