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 42 .
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.
Product history page 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018948-001 CARNITOR 330MG TABLET / ORAL AB RLD, RS 1985-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018948-002 CARNITOR 1GM/10ML SOLUTION / ORAL 1988-04-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
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