Home Applications 017010 Application 017010
Type NDA
Sponsor PERRIGO NEW YORK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DESONIDE DESONIDE CREAM;TOPICAL 0.05% Yes 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Approval date N017010-001 DESONIDE DESONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982
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 N017010-001 DESONIDE 0.05% CREAM / TOPICAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017010-001 DESONIDE 0.05% CREAM / TOPICAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017010-001 DESONIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982 a50c72e98297…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 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 42254-142 Desonide Desonide Rebel Distributors Corp NDA Current 45802-422 Desonide Desonide Perrigo New York Inc NDA Current 45802-422 Desonide Desonide Padagis Israel Pharmaceuticals Ltd NDA Current 45802-422 Desonide Desonide Padagis Israel Pharmaceuticals Ltd NDA Current 69482-600 Tridesilon Cream desonide 0.05% Encore Dermatology Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54289 ORIG 2018-05-22