ANDA 076162

WATSON LABS TEVA

FDA Drug Application

Application #076162

Documents

• Letter: 2004-10-18

Application Sponsors

ANDA 076162

WATSON LABS TEVA

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	50MG/VIAL	0	CARBOPLATIN	CARBOPLATIN
002	INJECTABLE;INJECTION	150MG/VIAL	0	CARBOPLATIN	CARBOPLATIN
003	INJECTABLE;INJECTION	450MG/VIAL	0	CARBOPLATIN	CARBOPLATIN

FDA Submissions

ORIG

1

AP

2004-10-14

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76162
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"150MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"450MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"150MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"450MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)