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 12 of 20 · 400 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 Warnings Name fallback generic name: HYDROCORTISONE Proctosol-HC HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 565284e7-4994-486b-8267-18bd166655ac 2025-07-02 Adverse reactions Name fallback generic name: HYDROCORTISONE Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Name fallback generic name: HYDROCORTISONE MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Name fallback generic name: HYDROCORTISONE Post-Treatment Repair Cream HYDROCORTISONE Vi Medical Products Inc. ab8885a9-0778-28ff-e053-2995a90a2e12 2025-06-19 Warnings Name fallback generic name: HYDROCORTISONE ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37cdfabc-1fdb-246a-e063-6394a90a008a 2025-06-17 Warnings Name fallback generic name: HYDROCORTISONE ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37ce6c35-b211-43de-e063-6294a90ab773 2025-06-17 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. f7aecfb4-c194-4554-8d05-4e46005e654b 2025-05-27 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA d57a59fb-c8f2-f73b-e053-2995a90a4cdb 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 4c96ec41-841c-322b-e054-00144ff8d46c 2025-05-08 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE ANI Pharmaceuticals, Inc. 0d7e8e04-9149-4436-bad1-b700e253b7ab 2025-05-05 Warnings, Adverse reactions Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE DermaCort Anti-itch HYDROCORTISONE Melaleuca, Inc. 24044b0f-dd1e-4762-82b8-7a28b08c2f77 2025-03-20 Warnings Name fallback generic name: HYDROCORTISONE Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone HYDROCORTISONE Walgreens Co. c22bba5c-bb6f-494e-987a-f6e36c1b4893 2025-03-06 Warnings Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE Thera Plus Hydrocortisone Maximum Strength HYDROCORTISONE FOURSTAR GROUP USA, INC. c2bc8f0c-38ea-4124-bc51-bf22e6751a92 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Eczema Hydrocortisone Anti Itch HYDROCORTISONE Fourstar Group USA, Inc. 7c72217b-db9a-4573-9f14-4c11528fa452 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc. fb89dca6-c0c0-4092-b3f5-e59c956c3d6c 2025-03-04 Warnings Name fallback generic name: HYDROCORTISONE Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 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