ANDA 205301

CADILA

FDA Drug Application

Application #205301

Application Sponsors

ANDA 205301

CADILA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

500MG

0

ACETAZOLAMIDE

ACETAZOLAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CADILA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205301
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"500MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-16
        )

)