Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203255
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIGNIFOR LAR KIT PASIREOTIDE PAMOATE EQ 20MG BASE/VIAL FOR SUSPENSION;INTRAMUSCULAR Prescription None Yes No
SIGNIFOR LAR KIT PASIREOTIDE PAMOATE EQ 40MG BASE/VIAL FOR SUSPENSION;INTRAMUSCULAR Prescription None Yes No
SIGNIFOR LAR KIT PASIREOTIDE PAMOATE EQ 60MG BASE/VIAL FOR SUSPENSION;INTRAMUSCULAR Prescription None Yes Yes
SIGNIFOR LAR KIT PASIREOTIDE PAMOATE EQ 10MG BASE/VIAL FOR SUSPENSION;INTRAMUSCULAR Prescription None Yes No
SIGNIFOR LAR KIT PASIREOTIDE PAMOATE EQ 30MG BASE/VIAL FOR SUSPENSION;INTRAMUSCULAR 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
12/15/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203255Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200677Orig1s004, 203255Orig1s005ltr.pdf
06/29/2018 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203255Orig1s004ltr.pdf
03/09/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf
07/08/2015 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
01/29/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s005lbl.pdf
06/29/2018 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf
03/09/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf
12/15/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf

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