Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/23/2014 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021883s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021883Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021883Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/24/2018 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021883s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021883Orig1s007ltr.pdf
01/20/2016 SUPPL-4 Labeling

Label is not available on this site.

01/20/2016 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021883Orig1s003ltr.pdf
12/18/2015 SUPPL-2 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021883Orig1s002ltr.pdf
11/20/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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