ANDA 065468

BRECKENRIDGE

FDA Drug Application

Application #065468

Application Sponsors

ANDA 065468

BRECKENRIDGE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

NEOMYCIN SULFATE

NEOMYCIN SULFATE

FDA Submissions

	ORIG	1	AP	2010-03-29
LABELING; Labeling	SUPPL	2	AP	2014-11-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AA

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65468
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN SULFATE","activeIngredients":"NEOMYCIN SULFATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN SULFATE","submission":"NEOMYCIN SULFATE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)