Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200181
Company: NOVEL LABS INC

Products on ANDA 200181

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENELZINE SULFATE	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200181

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200181

PHENELZINE SULFATE

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NARDIL	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	Yes	AB	011909	PARKE DAVIS
PHENELZINE SULFATE	PHENELZINE SULFATE	EQ 15MG BASE	TABLET;ORAL	Prescription	No	AB	200181	NOVEL LABS INC