NDA 016097

MERCK SHARP DOHME

FDA Drug Application

Application #016097

Documents

• Letter: 2001-06-29
• Letter: 2003-06-22
• Label: 2003-06-22

Application Sponsors

NDA 016097

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

500MG/5ML

0

MINTEZOL

THIABENDAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1967-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-02-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	1975-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-06-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	1976-09-09
LABELING; Labeling	SUPPL	12	AP	1977-05-03
LABELING; Labeling	SUPPL	13	AP	1978-04-17
LABELING; Labeling	SUPPL	15	AP	1983-11-09
LABELING; Labeling	SUPPL	17	AP	1985-04-01
LABELING; Labeling	SUPPL	18	AP	1987-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-01-23	STANDARD
LABELING; Labeling	SUPPL	21	AP	1985-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-04-04	STANDARD
LABELING; Labeling	SUPPL	23	AP	1996-06-03
LABELING; Labeling	SUPPL	24	AP	2001-06-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-10-24	STANDARD
LABELING; Labeling	SUPPL	26	AP	2003-06-11	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16097
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINTEZOL","activeIngredients":"THIABENDAZOLE","strength":"500MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/11\/2003","submission":"SUPPL-26","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\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2003-06-11
        )

)