Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076858
Company: RISING

Products on ANDA 076858

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCARNITINE	LEVOCARNITINE	330MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076858

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76858ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076858

LEVOCARNITINE

TABLET;ORAL; 330MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARNITOR	LEVOCARNITINE	330MG	TABLET;ORAL	Prescription	Yes	AB	018948	LEADIANT BIOSCI INC
LEVOCARNITINE	LEVOCARNITINE	330MG	TABLET;ORAL	Prescription	No	AB	216384	NOVITIUM PHARMA
LEVOCARNITINE	LEVOCARNITINE	330MG	TABLET;ORAL	Prescription	No	AB	076858	RISING