Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;SUBLINGUAL | 1.75MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
002 | TABLET;SUBLINGUAL | 3.5MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-09-11 | |
LABELING; Labeling | SUPPL | 2 | AP | 2020-07-02 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204229
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"1.75MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"3.5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/02\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/02\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-02
)
)