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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207145
Company: MDD US

Products on NDA 207145

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XADAGO	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
XADAGO	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207145

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2021	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207145s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207145Orig1s006ltr.pdf
11/25/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207145s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207145Orig1s005ltr.pdf
06/16/2017	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207145Orig1s001ltr.pdf

Labels for NDA 207145

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207145s006lbl.pdf
08/06/2021	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207145s006lbl.pdf
11/25/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207145s005lbl.pdf
11/25/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207145s005lbl.pdf
06/16/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145s001lbl.pdf
03/21/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207145lbl.pdf

Therapeutic Equivalents for NDA 207145

XADAGO

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	215978	MSN
SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	215739	PRINSTON INC
XADAGO	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	207145	MDD US

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	215978	MSN
SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	215739	PRINSTON INC
XADAGO	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	207145	MDD US

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