Home Applications 016785 Application 016785
Type NDA
Sponsor LEADIANT BIOSCI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MATULANE PROCARBAZINE HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE 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 N016785-001 MATULANE PROCARBAZINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL RLD, RS, 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.
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 N016785-001 MATULANE EQ 50MG BASE CAPSULE / ORAL RLD, RS, Approved before 1982 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Matulane PROCARBAZINE HYDROCHLORIDE Leadiant Biosciences, Inc. 1aa75a3a-18c9-49e1-91a6-293d0b7da756 2024-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 016785 application number: NDA016785 ndc (product): 54482-054
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54482-053 Matulane procarbazine hydrochloride Sigma-Tau Pharmaceuticals, Inc. NDA Current 54482-053 Matulane procarbazine hydrochloride Sigma-Tau Pharmaceuticals, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current 54482-054 Matulane procarbazine hydrochloride Leadiant Biosciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 13030 SUPPL 2003-01-29