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Drugs@FDA: FDA-Approved Drugs

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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AREDIA PAMIDRONATE DISODIUM 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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

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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