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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200677
Company: RECORDATI RARE

Medication Guide

Summary Review

Products on NDA 200677

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200677

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
01/15/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200677Orig1s006ltr.pdf
04/11/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200677Orig1s005ltr.pdf
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

Labels for NDA 200677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/15/2020	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200677s006lbl.pdf
04/11/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s005lbl.pdf
04/11/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200677s005lbl.pdf
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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