ANDA 208166

ZYDUS PHARMS

FDA Drug Application

Application #208166

Application Sponsors

ANDA 208166

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

6GM/30ML (200MG/ML)

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208166
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"6GM\/30ML (200MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-20
        )

)