NDA 001546

MERCK SHARP DOHME

FDA Drug Application

Application #001546

Documents

• Letter: 2002-04-24

Application Sponsors

NDA 001546

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

125MG

0

GUANIDINE HYDROCHLORIDE

GUANIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1939-10-02	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1975-01-29
LABELING; Labeling	SUPPL	5	AP	1976-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1978-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1980-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-12-11
LABELING; Labeling	SUPPL	11	AP	2002-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2015-08-03

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 1546
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUANIDINE HYDROCHLORIDE","activeIngredients":"GUANIDINE HYDROCHLORIDE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GUANIDINE HYDROCHLORIDE","submission":"GUANIDINE HYDROCHLORIDE","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)