ANDA 215223

ZYDUS PHARMS

FDA Drug Application

Application #215223

Application Sponsors

ANDA 215223

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1GM

0

COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215223
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLESTIPOL HYDROCHLORIDE","activeIngredients":"COLESTIPOL HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-10
        )

)