NDA 017530

PAR STERILE PRODUCTS

FDA Drug Application

Application #017530

Documents

• Letter: 2005-08-31
• Letter: 2005-08-31
• Label: 2004-06-18
• Label: 2005-08-31
• Label: 2005-08-31
• Label: 2008-06-05
• Letter: 2004-06-18
• Letter: 2005-08-31
• Letter: 2008-04-22
• Label: 2005-08-31
• Review: 2007-07-09

Application Sponsors

NDA 017530

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

1

TIGAN

TRIMETHOBENZAMIDE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1980-09-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	1981-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-02-23	STANDARD
LABELING; Labeling	SUPPL	18	AP	2002-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2005-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2005-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2005-08-26	STANDARD
LABELING; Labeling	SUPPL	24	AP	2008-04-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17530
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGAN","activeIngredients":"TRIMETHOBENZAMIDE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/18\/2008","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017530s024lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2005","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017530s021,022,023lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/26\/2005","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017530s021,022,023lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2005","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/017530s021,022,023lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2002","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/17531s10lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TIGAN","submission":"TRIMETHOBENZAMIDE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2008-04-18
        )

)