ANDA 205358

PAR STERILE PRODUCTS

FDA Drug Application

Application #205358

Documents

• Letter: 2017-06-26
• Label: 2017-06-27

Application Sponsors

ANDA 205358

PAR STERILE PRODUCTS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

ACETAZOLAMIDE SODIUM

ACETAZOLAMIDE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205358
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE SODIUM","activeIngredients":"ACETAZOLAMIDE SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205358Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205358Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205358rig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-06-20
        )

)