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 5 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortenema HYDROCORTISONE ANI Pharmaceuticals, Inc. a307448a-ccc4-41a8-977a-11f28f0bded9 2026-03-02 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Procto-Med HC HYDROCORTISONE NuCare Pharmaceuticals,Inc. 4b972547-5bd4-155d-e063-6394a90a03ee 2026-03-02 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE ANI Pharmaceuticals, Inc. 40654d12-56e4-4489-be49-19c60ad918ad 2026-03-02 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE PD-Rx Pharmaceuticals, Inc. 931ed426-89a1-4877-a4a5-cb963d51e717 2026-02-25 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A-S Medication Solutions a3fbdae4-d1dc-42de-939f-f9a7aab60e49 2026-02-24 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sportpharm LLC 9578b39e-3df7-4d75-abd7-f1d5524545e5 2026-02-23 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A-S Medication Solutions bb959c6f-7c9a-43c5-a45b-2ad9a87baa88 2026-02-18 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Medrock Pharmacy LLC 43e00e17-1a48-43db-9589-834568917bbf 2026-02-17 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Natureplex Hydrocortisone Hydro HYDROCORTISONE Natureplex, LLC 2fc6a148-34bb-4289-8588-32c1bb011b98 2026-02-13 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE CREAM 1% Aldermed Inc. 4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d 2026-02-10 Warnings Name fallback brand name: Hydrocortisone Aquanil HC HYDROCORTISONE Person and Covey 4a698246-05a6-d01f-e063-6294a90a3401 2026-02-09 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Sportpharm LLC ee64ad1e-78db-4553-a3cf-b539b770fa26 2026-02-06 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE CVS PHARMACY, INC 8b8cdb26-8e8f-4e95-9d83-d685c90afe01 2026-02-02 Warnings Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A-S Medication Solutions 5c4c3e02-5272-4a28-a9c8-1c5fa3ae181c 2026-01-30 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE ProCure Hydrocortisone Cream Plus HYDROCORTISONE Rooftop Consumer Health, Inc. fe334cae-e019-4397-8498-df3c923ae8b5 2026-01-29 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC bc374fa4-ac8b-408e-9321-8bab97a18770 2026-01-28 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 31fbb576-0e76-471c-83c8-9e0125bc1791 2026-01-28 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC bcd103f3-3dc8-4394-b8fd-8f8ddb721f77 2026-01-28 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone with Aloe HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC 4a113699-1eb7-49b8-8cdf-2ad57db89b81 2026-01-27 Warnings Name fallback generic name: HYDROCORTISONE Viaderma Calm Anti-Itch HYDROCORTISONE VIADERMA DISTRIBUTION INC ea281bde-a7a2-47b6-895a-5dc2924972de 2026-01-27 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 · 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