NDA 050108

PAR STERILE PRODUCTS

FDA Drug Application

Application #050108

Documents

• Letter: 2006-01-20
• Letter: 2009-05-19
• Label: 2009-06-07
• Label: 2013-03-08
• Letter: 2004-06-01
• Letter: 2013-03-08
• Label: 2006-01-13
• Other Important Information from FDA: 2007-06-29
• Label: 2017-04-18
• Letter: 2017-04-18

Application Sponsors

NDA 050108

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 002

Application Products

002

INJECTABLE;INJECTION

EQ 150MG BASE/VIAL

1

COLY-MYCIN M

COLISTIMETHATE SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	1970-06-04	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-03-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1970-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1970-12-22
LABELING; Labeling	SUPPL	7	AP	1970-12-19
LABELING; Labeling	SUPPL	8	AP	1971-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1972-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1973-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1975-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1976-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-12-08
LABELING; Labeling	SUPPL	16	AP	1979-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1980-01-18
LABELING; Labeling	SUPPL	18	AP	1980-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1981-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-04-28
LABELING; Labeling	SUPPL	21	AP	1999-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-09-28
LABELING; Labeling	SUPPL	23	AP	2002-12-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2006-01-12	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-05-13	STANDARD
LABELING; Labeling	SUPPL	30	AP	2013-03-07	STANDARD
LABELING; Labeling	SUPPL	33	AP	2017-04-14	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	30	Null	15
SUPPL	33	Null	7

TE Codes

002

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50108
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLY-MYCIN M","activeIngredients":"COLISTIMETHATE SODIUM","strength":"EQ 150MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/14\/2017","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050108s033lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/07\/2013","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050108s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/050108s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2006","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/050108s024lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COLY-MYCIN M","submission":"COLISTIMETHATE SODIUM","actionType":"EQ 150MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-04-14
        )

)