Home Applications 020892 Application 020892
Type NDA
Sponsor ENDO PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VALSTAR PRESERVATIVE FREE VALRUBICIN SOLUTION;INTRAVESICAL 40MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N020892-001 VALSTAR PRESERVATIVE FREE VALRUBICIN 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020892-001 AO
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.
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 2026-08-01 22:54:32 2026-06 N020892-001 VALSTAR PRESERVATIVE FREE 40MG/ML SOLUTION / INTRAVESICAL AO RLD, RS 1998-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N020892-001 AO 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67979-001 Valstar valrubicin Endo Pharmaceuticals Solutions Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Solutions Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Solutions Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Solutions Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Inc. NDA Current 67979-001 Valstar valrubicin Endo Pharmaceuticals Solutions Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 26125 SUPPL 2016-04-11 35576 SUPPL 2016-04-08 3659 SUPPL 2013-08-05 3658 SUPPL 2011-11-07 13674 SUPPL 2011-11-04 21045 ORIG 1998-09-25 13673 ORIG 1998-09-25 3657 ORIG 1998-09-25