Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075991
Company: CARLSBAD
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/05/2002 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-19 Labeling-Package Insert

Label is not available on this site.

12/01/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/29/2013 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/12/2012 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/22/2009 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/03/2010 SUPPL-12 Labeling

Label is not available on this site.

03/02/2006 SUPPL-7 Labeling

Label is not available on this site.

06/30/2004 SUPPL-2 Labeling

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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