Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021386
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOMETA ZOLEDRONIC ACID EQ 4MG BASE/VIAL INJECTABLE; IV (INFUSION) Prescription 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
02/22/2002 ORIG-1 Approval Type 6 - New Indication (no longer used) PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21223s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-386_Zometa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021386s004ltr.pdf
02/27/2004 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21223slr006,21386se8-001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/04/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021386s004lbl.pdf
02/27/2004 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021223s006lbl.pdf
02/22/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21386lbl.pdf

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