ANDA 204222

APOTEX

FDA Drug Application

Application #204222

Application Sponsors

ANDA 204222

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 3MG BASE/3ML

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-10-16

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204222
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 3MG BASE\/3ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/17\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-17
        )

)