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 6 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rapidol HYDROCORTISONE Pharmadel LLC 19a1f1e2-bc6b-7153-e063-6294a90ab115 2026-01-23 Warnings Name fallback generic name: HYDROCORTISONE Aveeno 1% Hydrocortisone Anti-Itch Cream HYDROCORTISONE Kenvue Brands LLC 1ac0ac4e-af76-9a3e-e063-6394a90a1269 2026-01-22 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone DRS. HYDROCORTISONE OL PHARMA TECH,LLC b0eac8f3-bb80-6563-e053-2995a90a83c9 2026-01-22 Warnings Name fallback brand name: Hydrocortisone Anti Itch HYDROCORTISONE HyVee Inc ae31f1f5-db70-45cf-850e-67bfe6860748 2026-01-21 Warnings Name fallback generic name: HYDROCORTISONE Skin Relief Cream HYDROCORTISONE Spa de Soleil 0a90b77a-4be4-71c5-e063-6294a90a8e41 2026-01-20 Warnings Name fallback generic name: HYDROCORTISONE Cortizone-10 Soothing Aloe Creme HYDROCORTISONE Chattem, Inc. 1a841bf0-9d7b-4566-b442-aa9bcc827846 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortisone 10 Sensitive Skin Creme HYDROCORTISONE Chattem, Inc. b139917c-00bb-4cb3-995d-a6d2f2c295c6 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone COOL RELIEF GEL WITH ALOE Walgreens 1ae2b37d-d5b2-74d2-e063-6294a90a0de0 2026-01-14 Warnings Name fallback brand name: Hydrocortisone Cortisone 10 Intensive Moisture Creme HYDROCORTISONE Chattem, Inc. 096a9af3-7e7c-4dae-bc22-44061c60d3c9 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Easy Relief HYDROCORTISONE Chattem, Inc. beb73818-cd88-44ff-8ecd-b02b910b53b7 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Feminine Itch Relief HYDROCORTISONE Chattem, Inc. c0c0c1fb-43c9-4903-bb3b-f0885619b8cc 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Ultra Soothing Creme HYDROCORTISONE Chattem, Inc. 4b62615f-e713-42f2-8b9c-9eebf8d1b270 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortizone 10 Fast Acting Itch Relief Cooling HYDROCORTISONE Chattem, Inc. 01cd77e3-380f-4487-ae6e-3ac45355d8a4 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 0174411c-1b10-4298-b820-87b24065b118 2026-01-14 Warnings Name fallback brand name: hydrocortisone generic name: HYDROCORTISONE Cortizone 10 Intensive Healing for Eczema HYDROCORTISONE Chattem, Inc. 31dc0f1f-ddd8-41dc-b669-b24655634d55 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Cortisone 10 Overnight Creme HYDROCORTISONE Chattem, Inc. ef2eda7e-d6a8-47e3-9d80-6074af6773dc 2026-01-14 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Crown Laboratories a84830ad-73dc-4a2e-b987-0a1103526535 2026-01-12 Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Alacort HYDROCORTISONE Crown Laboratories de000081-a245-4f6b-9e7c-e47d84b82338 2026-01-12 Adverse reactions Name fallback generic name: HYDROCORTISONE Texacort HYDROCORTISONE Mission Pharmacal Company 25279d46-6bad-471f-8bd6-736d53cfd942 2026-01-08 Adverse reactions Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Strides Pharma Inc. c58dfac3-a131-4b6b-bf75-ba46e5bc6ba6 2026-01-08 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone 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