Home Applications 017765 Application 017765
Type NDA
Sponsor EPI HLTH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLODERM CLOCORTOLONE PIVALATE CREAM;TOPICAL 0.1% Yes Yes
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 N017765-001 CLODERM CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB RLD, 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 N017765-001 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 N017765-001 CLODERM 0.1% CREAM / TOPICAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017765-001 CLODERM 0.1% CREAM / TOPICAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017765-001 CLODERM 0.1% CREAM / TOPICAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017765-001 CLODERM 0.1% CREAM / TOPICAL AB RLD, RS, 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 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43598-341 clocortolone pivalate clocortolone pivalate Dr. Reddy's Laboratories Inc NDA AUTHORIZED GENERIC Current 43598-341 clocortolone pivalate clocortolone pivalate Dr. Reddy's Laboratories Inc NDA AUTHORIZED GENERIC Current 66993-947 Clocortolone Pivalate Cream Clocortolone Pivalate Prasco Laboratories NDA AUTHORIZED GENERIC Current 66993-947 Clocortolone Pivalate Cream Clocortolone Pivalate Prasco Laboratories NDA AUTHORIZED GENERIC Current 67857-804 Cloderm clocortolone pivalate Promius Pharma, LLC NDA Current 67857-804 Cloderm clocortolone pivalate Promius Pharma, LLC NDA Current 71403-804 Cloderm clocortolone pivalate EPI Health, Inc NDA Current 71403-804 Cloderm clocortolone pivalate EPI Health, Inc NDA Current 71403-804 Cloderm clocortolone pivalate EPI Health, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 13894 SUPPL 2003-12-16 11058 SUPPL 2003-12-16