ANDA 205473

PAR STERILE PRODUCTS

FDA Drug Application

Application #205473

Documents

• Letter: 2015-08-03

Application Sponsors

ANDA 205473

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

ETHACRYNATE SODIUM

ETHACRYNATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-07-29

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205473
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHACRYNATE SODIUM","activeIngredients":"ETHACRYNATE SODIUM","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205473Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-29
        )

)