Drugs@FDA: FDA-Approved Drugs
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KINEVAC | SINCALIDE | 0.005MG/VIAL | POWDER;INTRAVENOUS | Prescription | AP | 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 |
KINEVAC
POWDER;INTRAVENOUS; 0.005MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KINEVAC | SINCALIDE | 0.005MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 017697 | BRACCO |
SINCALIDE | SINCALIDE | 0.005MG/VIAL | POWDER;INTRAVENOUS | Prescription | Yes | AP | 210850 | MAIA PHARMS INC |