ANDA 207684

CIPLA

FDA Drug Application

Application #207684

Application Sponsors

ANDA 207684

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

50MG/5ML

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207684
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"50MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-12-21
        )

)