NDA 016096

MERCK SHARP DOHME

FDA Drug Application

Application #016096

Documents

• Letter: 2001-06-19
• Letter: 2003-06-22
• Label: 2003-06-22

Application Sponsors

NDA 016096

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

500MG

0

MINTEZOL

THIABENDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1967-04-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1975-02-25	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1976-04-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-06-24	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1977-05-03
LABELING; Labeling	SUPPL	12	AP	1978-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-06-04	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1983-11-07
LABELING; Labeling	SUPPL	15	AP	1983-11-07
LABELING; Labeling	SUPPL	16	AP	1985-04-01
LABELING; Labeling	SUPPL	17	AP	1987-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1984-08-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-01-23	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1985-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-04-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1990-11-19	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1996-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1991-12-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1992-07-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1994-06-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-12-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1996-08-07	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2001-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-03-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-10-24	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2003-06-11	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16096
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINTEZOL","activeIngredients":"THIABENDAZOLE","strength":"500MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2003","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/16096slr033,16097slr026_mintezol_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MINTEZOL","submission":"THIABENDAZOLE","actionType":"500MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-06-11
        )

)