ANDA 210423

ALEMBIC PHARMS LTD

FDA Drug Application

Application #210423

Application Sponsors

ANDA 210423

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

500MG

0

ACETAZOLAMIDE

ACETAZOLAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210423
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"500MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-19
        )

)