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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075567
Company: HIKMA

Products on ANDA 075567

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 075567

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75567ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/16/2024	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/16/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/04/2002	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/23/2001	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075567

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/29/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine_prntlbl.pdf

Therapeutic Equivalents for ANDA 075567

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	217430	DEVA HOLDING AS
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075567	HIKMA

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