ANDA 065013

XGEN PHARMS

FDA Drug Application

Application #065013

Documents

• Label: 2012-07-30

Application Sponsors

ANDA 065013

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1.2GM BASE/VIAL

0

TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE

FDA Submissions

	ORIG	1	AP	2001-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-12-09
LABELING; Labeling	SUPPL	7	AP	2012-01-17
LABELING; Labeling	SUPPL	8	AP	2010-10-18
LABELING; Labeling	SUPPL	9	AP	2012-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2013-10-07
LABELING; Labeling	SUPPL	11	AP	2012-11-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2013-08-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	7	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	7

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65013
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 1.2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/17\/2012","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/065013s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOBRAMYCIN SULFATE","submission":"TOBRAMYCIN SULFATE","actionType":"EQ 1.2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-01-17
        )

)