ANDA 064210

XGEN PHARMS

FDA Drug Application

Application #064210

Documents

• Letter: 1998-06-30
• Label: 2012-07-30

Application Sponsors

ANDA 064210

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1GM BASE/VIAL

0

STREPTOMYCIN SULFATE

STREPTOMYCIN SULFATE

FDA Submissions

	ORIG	1	AP	1998-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-07-23
LABELING; Labeling	SUPPL	9	AP	2012-04-30
LABELING; Labeling	SUPPL	12	AP	2015-11-10	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	15
SUPPL	12	Null	15

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64210
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"STREPTOMYCIN SULFATE","activeIngredients":"STREPTOMYCIN SULFATE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/30\/2012","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/064210s009lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"STREPTOMYCIN SULFATE","submission":"STREPTOMYCIN SULFATE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-04-30
        )

)