Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076858
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOCARNITINE LEVOCARNITINE 330MG TABLET;ORAL Prescription AB No No
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.

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 076858 IMPAX LABS INC

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