Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075881
Company: TEVA PHARMS USA

Products on ANDA 075881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075881

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/2001/75-881_Levocarnitine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75881ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-881_Levocarnitine.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2012	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/11/2002	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075881

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/2001/75-881_Levocarnitine_prntlbl.pdf