ANDA 091260

APOTEX INC

FDA Drug Application

Application #091260

Documents

• Letter: 2011-08-26

Application Sponsors

ANDA 091260

APOTEX INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30MG

0

CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2011-08-25

Submissions Property Types

ORIG

1

Null

15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91260
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEVIMELINE HYDROCHLORIDE","activeIngredients":"CEVIMELINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEVIMELINE HYDROCHLORIDE","submission":"CEVIMELINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)