Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215739
Company: PRINSTON INC

Products on ANDA 215739

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215739

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215739

SAFINAMIDE MESYLATE

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	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	215739	PRINSTON INC
XADAGO	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	207145	MDD US