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 20 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone ANTIPRURITIC (ANTI-ITCH) BluePoint Laboratories d6523993-d781-cdbc-e053-2a95a90af191 2023-11-17 Warnings Name fallback brand name: Hydrocortisone TOTAL RELIEF HYDROCORTISONE DR. MARDER SKINCARE, LLC 2c05459c-5a2c-45ab-b534-87f966b41681 2023-11-11 Warnings Name fallback generic name: HYDROCORTISONE KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Name fallback generic name: HYDROCORTISONE SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Name fallback generic name: HYDROCORTISONE Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Name fallback generic name: HYDROCORTISONE Dr. Sheffield Hydrocortisone Anti itch HYDROCORTISONE Sheffield Pharmaceuticals LLC 71c9f2f4-2188-45eb-b55e-3856ac78070b 2023-10-30 Warnings Name fallback generic name: HYDROCORTISONE Thera plus Anti-itch with aloe Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. c69d0670-a65b-1680-e053-2995a90a2ee5 2023-10-26 Warnings Name fallback generic name: HYDROCORTISONE Assured HYDROCORTISONE Zhejiang Jingwei Pharmaceutic Al Co., Ltd. bc97f364-9443-47b8-9c2d-b5dcc00cc9b7 2023-10-25 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus HYDROCORTISONE Zhejiang Jingwei Pharmaceutical Co., Ltd. bcc99e5a-2403-46da-9c9d-8411fa4104e0 2023-10-25 Warnings Name fallback generic name: HYDROCORTISONE Family Wellness HYDROCORTISONE Zhejiang Jingwei Pharmaceutical Co., Ltd. cddc9c4a-7c58-4225-921a-05d6afb49178 2023-10-24 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Bryant Ranch Prepack b33f51f5-7506-43d3-863b-406dc5c7d167 2023-07-18 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE 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.
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