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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021883
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DALVANCE DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2021 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021883s010lbl.pdf
07/24/2018 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf
01/20/2016 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021883s003lbl.pdf
05/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf
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