ANDA 202561

AM REGENT

FDA Drug Application

Application #202561

Application Sponsors

ANDA 202561

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

CHLOROTHIAZIDE SODIUM

CHLOROTHIAZIDE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-04-22

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202561
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOROTHIAZIDE SODIUM","activeIngredients":"CHLOROTHIAZIDE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-04-22
        )

)