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 44 .
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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083365-001 HYDROCORTISONE 20MG TABLET / ORAL Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083365-002 HYDROCORTISONE 5MG TABLET / ORAL 2015-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A083365-003 HYDROCORTISONE 10MG TABLET / ORAL 2015-02-23 a50c72e98297…
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 1 of 20 · 389 matching rows.
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