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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020182
Company: LEADIANT BIOSCI INC

Products on NDA 020182

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARNITOR	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020182

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1992	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-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20182Orig1s015ltr.pdf
05/29/2015	SUPPL-13	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
04/15/2002	SUPPL-8	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
05/16/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/15/1999	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182S6_Carnitor.cfm
12/15/1998	SUPPL-5	Labeling		Label is not available on this site.
12/01/1997	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/27/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/10/1995	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/07/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020182

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf
05/29/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf
04/15/2002	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf
12/15/1999	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf

Therapeutic Equivalents for NDA 020182

CARNITOR

INJECTABLE;INJECTION; 200MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARNITOR	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020182	LEADIANT BIOSCI INC
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075861	AM REGENT
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075567	HIKMA

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