Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212533
Company: SAPTALIS PHARMS

Products on ANDA 212533

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212533

LEVOCARNITINE

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