WATSON LABS TEVA FDA Approval ANDA 075425

ANDA 075425

WATSON LABS TEVA

FDA Drug Application

Application #075425

Documents

Letter1999-07-29

Application Sponsors

ANDA 075425WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL200MG0CIMETIDINECIMETIDINE

FDA Submissions

ORIG1AP1999-07-29

CDER Filings

WATSON LABS TEVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75425
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIMETIDINE","activeIngredients":"CIMETIDINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIMETIDINE","submission":"CIMETIDINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.