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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019257
Company: LEADIANT BIOSCI INC

Products on NDA 019257

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARNITOR	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes
CARNITOR SF	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/1986	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018948Orig1s028,019257Orig1s014ltr.pdf
05/29/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf
03/28/2007	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf
04/15/2002	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf
12/15/1998	SUPPL-9	Labeling		Label is not available on this site.
01/27/1997	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/17/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/12/1995	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/1990	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/11/1988	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/12/1989	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019257

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf
05/29/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf
03/28/2007	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf
03/28/2007	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf
04/15/2002	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf

Therapeutic Equivalents for NDA 019257

CARNITOR

SOLUTION;ORAL; 1GM/10ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARNITOR	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	Yes	AA	019257	LEADIANT BIOSCI INC
CARNITOR SF	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	Yes	AA	019257	LEADIANT BIOSCI INC
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	076851	LYNE
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	211676	NOVITIUM PHARMA
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	212533	SAPTALIS PHARMS
LEVOCARNITINE SF	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	211676	NOVITIUM PHARMA

CARNITOR SF

SOLUTION;ORAL; 1GM/10ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARNITOR	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	Yes	AA	019257	LEADIANT BIOSCI INC
CARNITOR SF	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	Yes	AA	019257	LEADIANT BIOSCI INC
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	076851	LYNE
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	211676	NOVITIUM PHARMA
LEVOCARNITINE	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	212533	SAPTALIS PHARMS
LEVOCARNITINE SF	LEVOCARNITINE	1GM/10ML	SOLUTION;ORAL	Prescription	No	AA	211676	NOVITIUM PHARMA

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