Documents
Application Sponsors
ANDA 078195 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | NEVIRAPINE | NEVIRAPINE |
FDA Submissions
| ORIG | 1 | AP | 2012-05-22 | |
LABELING; Labeling | SUPPL | 13 | AP | 2020-01-02 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 78195
[companyName] => STRIDES PHARMA
[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
)
)