Application 020182

Type: NDA
Sponsor: LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARNITOR	LEVOCARNITINE	INJECTABLE;INJECTION	200MG/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
N020182-001	CARNITOR	LEVOCARNITINE	200MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020182-001	AP

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	N020182-001	CARNITOR	200MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-16	`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	N020182-001	AP	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carnitor	LEVOCARNITINE	Leadiant Biosciences, Inc.	cf801cc4-775e-433d-9d32-e5d9a98981d3	2023-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020182 application number: NDA020182 ndc (product): 54482-147

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current
54482-147	Carnitor	levocarnitine	Leadiant Biosciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53762	SUPPL	2018-04-20
53736	SUPPL	2018-04-19
34349	SUPPL	2015-06-04
24542	SUPPL	2015-06-02
24541	SUPPL	2002-04-15
12303	SUPPL	2002-04-15
20527	SUPPL	1999-12-15
12302	SUPPL	1999-12-15
2146	SUPPL	1999-12-15