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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203255
Company: RECORDATI RARE

Summary Review

Products on NDA 203255

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203255

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
07/09/2020	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203255Orig1s008ltr.pdf
04/11/2019	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203255Orig1s007ltr.pdf
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.

Labels for NDA 203255

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf
07/09/2020	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf
04/11/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf
04/11/2019	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf
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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