Home Applications 018948 Application 018948
Type NDA
Sponsor LEADIANT BIOSCI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARNITOR LEVOCARNITINE TABLET;ORAL 330MG Yes Yes 002 CARNITOR LEVOCARNITINE SOLUTION;ORAL 1GM/10ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018948-001 CARNITOR LEVOCARNITINE 330MG TABLET / ORAL AB RLD, RS 1985-12-27 N018948-002 CARNITOR LEVOCARNITINE 1GM/10ML SOLUTION / ORAL 1988-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018948-001 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.
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 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 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 N018948-001 AB 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-172 Levocarnitine Levocarnitine Hi-Tech Pharmacal Co., Inc. NDA Current 50383-172 Levocarnitine Levocarnitine Hi-Tech Pharmacal Co., Inc. NDA Current 50383-172 Levocarnitine Levocarnitine Hi-Tech Pharmacal Co., Inc. NDA Current 50383-172 Levocarnitine Levocarnitine Akorn NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current 54482-144 CARNITOR levocarnitine Leadiant Biosciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 57624 ORIG 2019-02-15 53759 SUPPL 2018-04-20 53734 SUPPL 2018-04-19 33671 SUPPL 2015-06-04 1149 SUPPL 2015-06-02 16127 SUPPL 2007-04-09 33670 SUPPL 2007-03-31 33669 SUPPL 2002-04-15 1148 SUPPL 2002-04-15 20170 SUPPL 1998-05-07