NDA 020408

MERCK

FDA Drug Application

Application #020408

Documents

• Letter: 2002-04-12
• Letter: 2002-04-09
• Letter: 2010-06-22
• Label: 2002-04-12
• Label: 2004-05-03
• Label: 2010-06-24
• Label: 2014-02-06
• Review: 2008-07-31
• Letter: 2004-04-20
• Letter: 2006-01-19
• Letter: 2008-10-24
• Letter: 2014-02-10
• Label: 2002-04-09
• Label: 2006-01-05
• Label: 2008-11-07
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Amendment 2: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2020-12-23
• Label: 2020-12-28

Application Sponsors

NDA 020408

MERCK

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE

1

TRUSOPT

DORZOLAMIDE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-12-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-03-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-07-22	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1998-08-03	STANDARD
LABELING; Labeling	SUPPL	7	AP	1998-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-02-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-06-13	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1998-08-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	1998-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-12-12	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1998-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-10-19	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1998-12-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	1999-06-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	1999-09-27	STANDARD
LABELING; Labeling	SUPPL	19	AP	2000-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-01-18	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2000-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-12-04	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2002-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-04-15	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2002-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2002-04-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2002-12-06	PRIORITY
EFFICACY; Efficacy	SUPPL	33	AP	2004-04-15	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2005-12-16	STANDARD
LABELING; Labeling	SUPPL	45	AP	2008-10-22	STANDARD
LABELING; Labeling	SUPPL	47	AP	2010-06-18	STANDARD
LABELING; Labeling	SUPPL	50	AP	2014-02-03	STANDARD
LABELING; Labeling	SUPPL	52	AP	2020-12-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	33	Null	8
SUPPL	47	Null	7
SUPPL	50	Null	7
SUPPL	52	Null	7

TE Codes

001

Prescription

AT

CDER Filings

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