WATSON LABS TEVA FDA Approval ANDA 077063

ANDA 077063

WATSON LABS TEVA

FDA Drug Application

Application #077063

Application Sponsors

ANDA 077063WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001SOLUTION;INHALATIONEQ 0.083% BASE;0.017%0ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEALBUTEROL SULFATE; IPRATROPIUM BROMIDE

FDA Submissions

ORIG1AP2007-12-31
ORIG13TA2007-04-13

Submissions Property Types

SUPPL13Null0

TE Codes

001PrescriptionAN

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77063
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"EQ 0.083% BASE;0.017%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE","submission":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","actionType":"EQ 0.083% BASE;0.017%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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