MYLAN PHARMS INC FDA Approval ANDA 091225

ANDA 091225

MYLAN PHARMS INC

FDA Drug Application

Application #091225

Application Sponsors

ANDA 091225MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001CAPSULE;ORALEQ 75MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE
002CAPSULE;ORALEQ 150MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE
003CAPSULE;ORALEQ 300MG BASE0CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDE

FDA Submissions

ORIG1AP2011-05-31

Submissions Property Types

ORIG1Null42

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91225
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN HYDROCHLORIDE","activeIngredients":"CLINDAMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLINDAMYCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLINDAMYCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLINDAMYCIN HYDROCHLORIDE","submission":"CLINDAMYCIN HYDROCHLORIDE","actionType":"EQ 300MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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