Home Applications 083201 Application 083201
Type ANDA
Sponsor CROWN LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALA-CORT HYDROCORTISONE LOTION;TOPICAL 1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A083201-001 ALA-CORT HYDROCORTISONE 1% LOTION / TOPICAL Approved before 1982
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083201-001 ALA-CORT 1% LOTION / TOPICAL Approved before 1982 cb3db0bc1861…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 19 · 368 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join hydrocortisone HYDROCORTISONE Eywa Pharma Inc b3f06d10-2f01-428c-88a4-505c61c87ce8 2026-07-25 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE AEROSOOTHE HYDROCORTISONE Aero Healthcare US LLC 22b172a2-07e8-4ebb-b0a0-dfe4f25477fa 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5763b4de-06f2-7b19-e063-6294a90ad068 2026-07-24 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE AKRON PHARMA INC daad9a1e-98d2-4ce7-9d97-ac5d81905abb 2026-07-22 Warnings Name fallback generic name: HYDROCORTISONE LYEON Anti-itch Cream HYDROCORTISONE Guangzhou Xinhongda Trading Service Co., Ltd. 56b773ce-167f-7873-e063-6394a90a9816 2026-07-16 Warnings Name fallback generic name: HYDROCORTISONE Barmicil Plus HYDROCORTISONE OPMX LLC 5698207f-9223-f3a6-e063-6294a90a8ab6 2026-07-14 Warnings Name fallback generic name: HYDROCORTISONE Quadriderm NF HYDROCORTISONE OPMX LLC 5643f850-e0d4-d8d8-e063-6294a90a4260 2026-07-10 Warnings Name fallback generic name: HYDROCORTISONE Drs. Hydrocortisone Aloe Vera HYDROCORTISONE OL PHARMA TECH,LLC 0df06415-5d32-7ef8-e063-6294a90a6e5a 2026-07-09 Warnings Name fallback generic name: HYDROCORTISONE Ala-Scalp HYDROCORTISONE Derm Ventures LLC 61498a40-3b3c-4066-89c8-d99686e2d638 2026-07-08 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE DIPROSPAN HYDROCORTISONE OPMX LLC 55fa9ecb-b843-5748-e063-6294a90a2d53 2026-07-06 Warnings Name fallback generic name: HYDROCORTISONE CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Encube Ethicals, Inc. 11e120e2-a1ca-477c-b474-bcbb72656705 2026-06-26 Adverse reactions Name fallback generic name: HYDROCORTISONE Medi-First Hydrocortisone 1 % Anti-Itch Cream HYDROCORTISONE Unifirst First Aid Corporation 49f04e5d-746d-cbe9-e063-6294a90a7e88 2026-06-16 Warnings Name fallback generic name: HYDROCORTISONE Hydroxym HYDROCORTISONE PureTek Corporation febffc84-e65e-e811-e053-6294a90a0ad1 2026-06-15 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone 1% Anti-ItchCream HYDROCORTISONE Acme United Corporation 5425fc2b-4f25-3e64-e063-6394a90aff49 2026-06-13 Warnings Name fallback generic name: HYDROCORTISONE good sense anti itch HYDROCORTISONE Preferred Pharmaceuticals Inc. e51047da-8e17-4dd7-be3c-54820a7485f2 2026-06-09 Warnings Name fallback generic name: HYDROCORTISONE Walgreens Scalp Itch Relief HYDROCORTISONE Walgreens 34952272-1f9e-c642-e063-6394a90ae2bd 2026-05-29 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Mylan Pharmaceuticals Inc. bc751403-94f2-4f9d-b533-cf6186a40ceb 2026-05-25 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 858053a0-d888-4bb9-b94e-503bcf3864cb 2026-05-21 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 04758c46-0ca4-4852-acdc-1f8553ce2e6e 2026-05-21 Adverse reactions Name fallback generic name: HYDROCORTISONE