ANDA 076602

PLIVA

FDA Drug Application

Application #076602

Application Sponsors

ANDA 076602

PLIVA

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

2004-11-16

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76602
            [companyName] => PLIVA
            [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
        )

)