MYLAN PHARMS INC FDA Approval ANDA 091294

ANDA 091294

MYLAN PHARMS INC

FDA Drug Application

Application #091294

Documents

Letter2012-06-20
Review2020-03-19

Application Sponsors

ANDA 091294MYLAN PHARMS INC

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 300MG BASE0ABACAVIR SULFATEABACAVIR SULFATE

FDA Submissions

ORIG1AP2012-06-18
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2015-12-11UNKNOWN
LABELING; LabelingSUPPL4AP2015-12-11STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null7

TE Codes

001PrescriptionAB

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91294
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE","activeIngredients":"ABACAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABACAVIR SULFATE","submission":"ABACAVIR SULFATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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