Home Applications 080693 Application 080693
Type ANDA
Sponsor FOUGERA PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 HYDROCORTISONE HYDROCORTISONE CREAM;TOPICAL 1% No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080693-003 HYDROCORTISONE HYDROCORTISONE 1% CREAM / TOPICAL AT RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080693-003 AT
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 2 of 2 · 43 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 2022-09-29 23:25 UTC 2022-09 A080693-003 HYDROCORTISONE 1% CREAM / TOPICAL AT RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A080693-003 HYDROCORTISONE 1% CREAM / TOPICAL AT RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A080693-003 HYDROCORTISONE 1% CREAM / TOPICAL AT RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 1 · 1 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 0168-0015 hydrocortisone Hydrocortisone E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0015 hydrocortisone Hydrocortisone E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. ANDA Current 21695-529 Hydrocortisone Hydrocortisone Rebel Distributors Corp ANDA Current 43063-228 Hydrocortisone Hydrocortisone PD-Rx Pharmaceuticals, Inc. ANDA Current 49999-139 Hydrocortisone Hydrocortisone Lake Erie Medical DBA Quality Care Products LLC ANDA Current