Home Applications 020273 Application 020273
Type NDA
Sponsor LEO PHARMA AS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOVONEX CALCIPOTRIENE OINTMENT;TOPICAL 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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date N020273-001 DOVONEX CALCIPOTRIENE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL AB RLD 1993-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020273-001 AB
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 · 44 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UTC 2022-10 N020273-001 DOVONEX 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL AB RLD 1993-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020273-001 DOVONEX 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD 1993-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020273-001 DOVONEX 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD 1993-12-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020273-001 DOVONEX 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL AB RLD 1993-12-29 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 66993-878 calcipotriene calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-878 calcipotriene calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-878 calcipotriene calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-878 calcipotriene calcipotriene Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-878 calcipotriene calcipotriene Prasco Laboratories NDA AUTHORIZED Current
Documents# Document, Submission type, Date table Document Submission type Date 83681 SUPPL 2025-10-07 83671 SUPPL 2025-10-06 12410 SUPPL 2015-03-17 2285 SUPPL 2015-03-13 41263 SUPPL 2009-01-12 12409 SUPPL 2007-10-04 2284 SUPPL 2007-10-04 34461 SUPPL 2005-05-02 24715 SUPPL 2005-05-02 20582 SUPPL 1999-07-07 2283 SUPPL 1999-07-07