ANDA 210434

CIPLA LTD

FDA Drug Application

Application #210434

Documents

• Letter: 2018-09-25

Application Sponsors

ANDA 210434

CIPLA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

ALBENDAZOLE

ALBENDAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210434
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBENDAZOLE","activeIngredients":"ALBENDAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210434Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-24
        )

)