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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202799
Company: TAKEDA PHARMS USA

Medication Guide

REMS

Products on NDA 202799

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMONTYS	PEGINESATIDE ACETATE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS	PEGINESATIDE ACETATE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No
OMONTYS PRESERVATIVE FREE	PEGINESATIDE ACETATE	EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202799_Omontys_Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2012	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202799Orig1s001ltr.pdf

Labels for NDA 202799

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2012	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf
12/04/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s001lbl.pdf
03/27/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202799s000lbl.pdf

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