Home Applications 083365 Application 083365
Type ANDA
Sponsor HIKMA INTL PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 20MG No No 002 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 5MG No No 003 HYDROCORTISONE HYDROCORTISONE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083365-001 HYDROCORTISONE HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 A083365-002 HYDROCORTISONE HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 A083365-003 HYDROCORTISONE HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23
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 4 · 129 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 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 301d65b070ca…
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 13 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Name fallback generic name: HYDROCORTISONE CORTEF HYDROCORTISONE Pharmacia & Upjohn Company LLC 9ce19944-dd88-4a7b-84ca-b07f4ec23bad 2025-02-17 Warnings, Adverse reactions Name fallback generic name: HYDROCORTISONE signature care Hydrocortisone HYDROCORTISONE Safeway 9fe16fc5-77e3-47f5-a943-85bc6565c0d4 2025-02-06 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc ded2eb00-88ce-42b7-858e-4645c6f13239 2025-02-05 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Bryant Ranch Prepack 0cb39a3d-4d3b-4820-b3bd-eff642e08a41 2025-01-28 Adverse reactions Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Gerigentle HYDROCORTISONE GERI-GENTLE CORPORATION 0adfa2f0-9758-5c54-e063-6294a90a461f 2025-01-25 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE DIRECT RX c28c3ceb-1807-b43b-e053-2995a90a2aba 2025-01-17 Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE Equate Hydrocortisone Topical HYDROCORTISONE WalMart 1f64555d-f77e-4a83-b222-fdb3ed7d8853 2025-01-16 Warnings Name fallback generic name: HYDROCORTISONE Equate Hydrocortisone HYDROCORTISONE WalMart f5c32b4a-1159-4b7a-b8ac-256d53020dc2 2025-01-16 Warnings Name fallback generic name: HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE AvPAK f3956208-291c-7374-e053-2a95a90a4628 2025-01-09 Warnings, Adverse reactions Name fallback brand name: HYDROCORTISONE generic name: HYDROCORTISONE ANTI ITCH HYDROCORTISONE Safeway 0bfa1653-76b7-48ed-a896-a0b5fc3bd794 2025-01-08 Warnings Name fallback generic name: HYDROCORTISONE AVON HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. 8f2aa11d-d794-6f3e-e053-2995a90a1d9d 2025-01-01 Warnings Name fallback generic name: HYDROCORTISONE HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. b9d033f3-4d12-a2c8-e053-2995a90ac7f1 2025-01-01 Warnings Name fallback generic name: HYDROCORTISONE FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE Lovely Skin, Inc. c12af4c6-2f05-46ec-b901-1a4fcd750180 2024-12-31 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Safeway af2e2ef3-0f3f-4592-8081-b6553ade2f5a 2024-12-26 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Hydrocortisone Cream with Aloe HYDROCORTISONE Rugby Laboratories 132982ea-cce6-687c-e063-6294a90a4632 2024-12-20 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE 1% Pharmacy Value Alliance LLC 9bb98452-a605-5c20-e053-2995a90a1ea7 2024-12-20 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0143-1252 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0143-1253 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0143-1254 Hydrocortisone Hydrocortisone West-Ward Pharmaceuticals Corp ANDA Current 0904-2674 Hydrocortisone Hydrocortisone Major Pharmaceuticals ANDA Current 43063-386 Hydrocortisone Hydrocortisone PD-Rx Pharmaceuticals, Inc. ANDA Current