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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017697
Company: BRACCO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KINEVAC SINCALIDE 0.005MG/VIAL INJECTABLE;INJECTION 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
07/21/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2023 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017697s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017697Orig1s038ltr.pdf
12/18/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017697Orig1s033ltr.pdf
03/21/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017697Orig1s032ltr.pdf
02/09/2018 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017697Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017697Orig1s031.pdf
02/17/2016 SUPPL-27 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/017697Orig1s027.pdf
08/18/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
05/29/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
01/22/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
07/18/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
04/26/2005 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017697s017ltr.pdf
11/27/2002 SUPPL-15 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s015.pdf
11/27/2002 SUPPL-14 Manufacturing (CMC)-Packaging Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s014.pdf
11/27/2002 SUPPL-13 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s013.pdf
11/27/2002 SUPPL-12 Manufacturing (CMC) Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17697scm012,scf013,scp014,scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017697Orig1s012.pdf
10/29/2002 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
12/22/1992 SUPPL-10 Labeling

Label is not available on this site.
05/25/1988 SUPPL-9 Labeling

Label is not available on this site.
07/15/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/25/1986 SUPPL-5 Efficacy-New Indication

Label is not available on this site.
10/18/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
09/14/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/17/2023 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017697s038lbl.pdf
12/18/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s033lbl.pdf
03/21/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s032lbl.pdf
02/09/2018 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s031lbl.pdf
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