Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075636
Company: SANDOZ
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
12/17/2001 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075636.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2017 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

11/02/2014 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

03/25/2013 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

10/09/2012 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

05/30/2012 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

02/16/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/15/2005 SUPPL-7 Labeling

Label is not available on this site.

12/20/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/2005 SUPPL-2 Labeling

Label is not available on this site.

12/12/2002 SUPPL-1 Manufacturing (CMC)

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 075300 BEXIMCO PHARMS USA
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 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 075300 BEXIMCO PHARMS USA
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 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 075300 BEXIMCO PHARMS USA
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 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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