Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206843
Company: BRISTOL-MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription None Yes No
DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription None Yes Yes
DAKLINZA DACLATASVIR DIHYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription None Yes 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
07/24/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206843Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206843Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2017 SUPPL-6 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206843Orig1s006ltr.pdf
12/21/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/13/2016 SUPPL-4 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf
02/05/2016 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf
02/05/2016 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s002ltr.pdf
02/05/2016 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206843Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206843Orig1s001,s003TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/206843Orig1s001, s003SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/14/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf
02/14/2017 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf
04/13/2016 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s004lbl.pdf
02/05/2016 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
02/05/2016 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
02/05/2016 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206843s001s002s003lbl.pdf
07/24/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206843Orig1s000lbl.pdf

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