U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075551
Company: TEVA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription AB No No
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription AB No No
LOVASTATIN LOVASTATIN 10MG 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/2001/075551.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2020 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
09/25/2020 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
11/02/2014 SUPPL-24 Labeling-Package Insert

Label is not available on this site.
01/29/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.
05/02/2012 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
04/14/2009 SUPPL-19 Labeling

Label is not available on this site.
10/05/2007 SUPPL-13 Labeling

Label is not available on this site.
03/13/2006 SUPPL-12 Labeling

Label is not available on this site.
03/02/2006 SUPPL-10 Labeling

Label is not available on this site.
08/18/2005 SUPPL-9 Labeling

Label is not available on this site.
08/18/2005 SUPPL-2 Labeling

Label is not available on this site.

LOVASTATIN

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 075991 CARLSBAD
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075300 CHARTWELL RX
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 077748 COREPHARMA
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 075636 EPIC PHARMA LLC
LOVASTATIN LOVASTATIN 40MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 40MG 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 075991 CARLSBAD
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075300 CHARTWELL RX
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 077748 COREPHARMA
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075636 EPIC PHARMA LLC
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 20MG TABLET;ORAL Prescription No AB 075551 TEVA

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 075991 CARLSBAD
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075300 CHARTWELL RX
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 077748 COREPHARMA
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075636 EPIC PHARMA LLC
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 078296 LUPIN
LOVASTATIN LOVASTATIN 10MG TABLET;ORAL Prescription No AB 075551 TEVA
Back to Top