ANDA 077169

ELITE LABS INC

FDA Drug Application

Application #077169

Application Sponsors

ANDA 077169

ELITE LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	2.5MG	0	ISRADIPINE	ISRADIPINE
002	CAPSULE;ORAL	5MG	0	ISRADIPINE	ISRADIPINE

FDA Submissions

ORIG

1

AP

2006-04-24

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ELITE LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77169
            [companyName] => ELITE LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISRADIPINE","activeIngredients":"ISRADIPINE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISRADIPINE","activeIngredients":"ISRADIPINE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISRADIPINE","submission":"ISRADIPINE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ISRADIPINE","submission":"ISRADIPINE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)