ANDA 075469

WATSON LABS TEVA

FDA Drug Application

Application #075469

Documents

• Letter: 2004-05-28
• Letter: 2000-09-25

Application Sponsors

ANDA 075469

WATSON LABS TEVA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	2.5MG;6.25MG	0	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	5MG;6.25MG	0	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
003	TABLET;ORAL	10MG;6.25MG	0	BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE	BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

FDA Submissions

ORIG

1

AP

2000-09-25

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75469
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"2.5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"5MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","activeIngredients":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","strength":"10MG;6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"2.5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"5MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE","submission":"BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE","actionType":"10MG;6.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)