ANDA 090688

MACLEODS PHARMS LTD

FDA Drug Application

Application #090688

Documents

• Letter: 2009-04-03

Application Sponsors

ANDA 090688

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

200MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

ORIG

1

AP

2019-01-14

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90688
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEVIRAPINE","submission":"NEVIRAPINE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)