ANDA 213041

APTAPHARMA INC

FDA Drug Application

Application #213041

Application Sponsors

ANDA 213041

APTAPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 10MG BASE/ML

0

SILDENAFIL CITRATE

SILDENAFIL CITRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

APTAPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213041
            [companyName] => APTAPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILDENAFIL CITRATE","activeIngredients":"SILDENAFIL CITRATE","strength":"EQ 10MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/06\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-06
        )

)