ANDA 215210

ZYDUS

FDA Drug Application

Application #215210

Application Sponsors

ANDA 215210

ZYDUS

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

1%

0

IVERMECTIN

IVERMECTIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215210
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IVERMECTIN","activeIngredients":"IVERMECTIN","strength":"1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-02
        )

)