Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021316
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALTOPREV LOVASTATIN 10MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ALTOPREV LOVASTATIN 20MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ALTOPREV LOVASTATIN 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ALTOPREV LOVASTATIN 60MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes 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
06/26/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/04/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021316s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021316Orig1s034ltr.pdf
09/14/2015 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/30/2014 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021316Orig1s031ltr.pdf
05/15/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/31/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s029ltr.pdf
12/21/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s028ltr.pdf
04/26/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316s026ltr.pdf
02/01/2007 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021316s018ltr.pdf
07/21/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21316s010ltr.pdf
09/24/2003 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021316_S006_ALTOCAR_TABLETS_AP.pdf
08/20/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr005ltr.pdf
12/18/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/11/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_S001_ALTOCOR_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/04/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021316s034lbl.pdf
04/30/2014 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf
12/21/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf
10/31/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf
04/26/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf
07/21/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf
09/24/2003 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf
09/11/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf
06/26/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf

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