Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077748
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription AB No No
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription AB No No
LOVASTATIN LOVASTATIN 40MG 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
02/28/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2017 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/02/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/02/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/09/2009 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LOVASTATIN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075828 ACTAVIS ELIZABETH
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 077748 APOTEX INC
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075991 CARLSBAD
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075451 MYLAN
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075300 SANDOZ
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075636 SANDOZ
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 077520 SUN PHARM INDUSTRIES
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075551 TEVA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075828 ACTAVIS ELIZABETH
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 077748 APOTEX INC
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075991 CARLSBAD
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075451 MYLAN
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075300 SANDOZ
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075636 SANDOZ
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 077520 SUN PHARM INDUSTRIES
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075551 TEVA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075828 ACTAVIS ELIZABETH
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 077748 APOTEX INC
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075991 CARLSBAD
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075451 MYLAN
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075300 SANDOZ
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075636 SANDOZ
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 077520 SUN PHARM INDUSTRIES
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075551 TEVA

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