Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020036
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AREDIA PAMIDRONATE DISODIUM 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
AREDIA PAMIDRONATE DISODIUM 60MG/VIAL INJECTABLE;INJECTION Discontinued None No No
AREDIA PAMIDRONATE DISODIUM 90MG/VIAL INJECTABLE;INJECTION Discontinued None 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
10/31/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036_apvl_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020036_aredia_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2012 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020036s041ltr.pdf
04/07/2011 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020036s039ltr.pdf
12/12/2008 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020036s035ltr.pdf
12/11/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020036s034ltr.pdf
11/16/2005 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s032ltr.pdf
10/11/2005 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s031ltr.pdf
02/02/2005 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20036s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020036_s030_Aredia.pdf
03/24/2004 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr029ltr.pdf
01/09/2004 SUPPL-28 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020036_S028_AREDIA.pdf
07/12/2002 SUPPL-26 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20036se8026ltr.pdf
02/12/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/20/2001 SUPPL-24 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20036s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-036S024_Aredia.pdf
11/15/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/07/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2003 SUPPL-20 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20036slr020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020036_S020_AREDIA.pdf
03/31/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/22/1998 SUPPL-16 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016_Aredia_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016.cfm
09/22/1998 SUPPL-15 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia.cfm
09/10/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/05/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/16/1996 SUPPL-11 Efficacy-New Indication

Label is not available on this site.

09/01/1995 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

12/08/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1994 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

04/17/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1993 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf
04/15/1994 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036s004_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s004_pkg.pdf
07/21/1992 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s003_ltr_lbl.pdf
05/06/1993 SUPPL-2 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf
05/06/1993 SUPPL-1 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/31/2012 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf
04/07/2011 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf
12/12/2008 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf
12/11/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf
11/16/2005 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf
10/11/2005 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf
02/02/2005 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf
08/20/2001 SUPPL-24 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf
04/15/1994 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf
10/31/1991 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf

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