ANDA 213181

AJANTA PHARMA LTD

FDA Drug Application

Application #213181

Application Sponsors

ANDA 213181

AJANTA PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

EQ 125MG VALPROIC ACID

0

DIVALPROEX SODIUM

DIVALPROEX SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213181
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-28
        )

)