NDA 020752

MERCK

FDA Drug Application

Application #020752

Documents

• Letter: 1998-05-28
• Review: 2005-06-23
• Review: 2007-07-09
• Letter: 2002-06-06
• Label: 1998-05-28
• Label: 2002-06-06
• Review: 1999-03-18

Application Sponsors

NDA 020752

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	0	PEPCID RPD	FAMOTIDINE
002	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	0	PEPCID RPD	FAMOTIDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-05-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1999-03-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2000-11-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2001-04-25	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2002-06-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2001-03-14	STANDARD

Submissions Property Types

SUPPL

5

Null

6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20752
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)