NDA 011909

PARKE DAVIS

FDA Drug Application

Application #011909

Documents

• Letter: 2003-09-09
• Letter: 2007-08-07
• Label: 2003-09-09
• Label: 2007-02-21
• Letter: 2005-02-23
• Letter: 2007-02-12
• Other Important Information from FDA: 2007-05-09
• Label: 2007-08-03
• Medication Guide: 2009-11-19
• Review: 2021-12-07

Application Sponsors

NDA 011909

PARKE DAVIS

Marketing Status

• Prescription: 002

Application Products

002

TABLET;ORAL

EQ 15MG BASE

1

NARDIL

PHENELZINE SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1961-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-08-27	STANDARD
LABELING; Labeling	SUPPL	9	AP	1978-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-08-27	STANDARD
LABELING; Labeling	SUPPL	12	AP	1982-11-03
LABELING; Labeling	SUPPL	13	AP	1985-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1994-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1998-02-25	STANDARD
LABELING; Labeling	SUPPL	30	AP	2002-01-03	STANDARD
LABELING; Labeling	SUPPL	33	AP	2003-09-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2005-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2007-02-06	N/A
LABELING; Labeling	SUPPL	38	AP	2007-08-02	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0

TE Codes

002

Prescription

AB

CDER Filings

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        )

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