FDA.reportPublic FDA data

Application 019257

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARNITORLEVOCARNITINESOLUTION;ORAL1GM/10MLYesYes
002CARNITOR SFLEVOCARNITINESOLUTION;ORAL1GM/10MLYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019257-001CARNITORLEVOCARNITINE1GM/10MLSOLUTION / ORALAARLD, RS1986-04-10
N019257-002CARNITOR SFLEVOCARNITINE1GM/10MLSOLUTION / ORALAARLD2007-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N019257-001AA
N019257-002AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N019257-001CARNITOR1GM/10MLSOLUTION / ORALAARLD, RS1986-04-10a50c72e98297…
2026-08-01 22:54:322026-06N019257-002CARNITOR SF1GM/10MLSOLUTION / ORALAARLD2007-03-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019257-001AA1a50c72e98297…
2026-08-01 22:54:322026-06N019257-002AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carnitor SFLEVOCARNITINELeadiant Biosciences, Inc.dd904490-83f3-4cd3-bb6f-68e28509b4b62024-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 019257
application number: NDA019257
ndc (product): 54482-148
CarnitorLEVOCARNITINELeadiant Biosciences, Inc.b2cbc620-59fd-47b6-9e4b-7e3e31533a1c2024-01-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 019257
application number: NDA019257
ndc (product): 54482-145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-171LevocarnitineLevocarnitineHi-Tech Pharmacal Co., Inc.NDACurrent
50383-171LevocarnitineLevocarnitineAkornNDACurrent
50383-171LevocarnitineLevocarnitineAkornNDACurrent
50383-171LevocarnitineLevocarnitineHi-Tech Pharmacal Co., Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53760SUPPL2018-04-20
53735SUPPL2018-04-19
11460SUPPL2015-06-04
17336SUPPL2015-06-02
1262SUPPL2007-04-09
11459SUPPL2007-03-31
33711SUPPL2002-04-15
1261SUPPL2002-04-15