Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075861
Company: AM REGENT

Products on ANDA 075861

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75861ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/15/2022	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 075861

LEVOCARNITINE

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