Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | 250MG/5ML | 0 | GABAPENTIN | GABAPENTIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-12-03 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-06-25 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 211330
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"250MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/03\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-12-03
)
)