Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200677
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIGNIFOR PASIREOTIDE DIASPARTATE EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes No
SIGNIFOR PASIREOTIDE DIASPARTATE EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes No
SIGNIFOR PASIREOTIDE DIASPARTATE EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) SOLUTION;SUBCUTANEOUS 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
12/14/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200677lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200677Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2019 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200677Orig1s004, 203255Orig1s005ltr.pdf
03/09/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200677s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf
03/17/2015 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200677s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200677Orig1s002ltr.pdf
02/13/2013 SUPPL-1 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200677Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s004lbl.pdf
03/09/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200677s003lbl.pdf
03/17/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200677s002lbl.pdf
12/14/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200677lbl.pdf

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