Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | EQ 2MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 4MG BASE | 0 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-01-26 | STANDARD |
Submissions Property Types
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207170
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TIZANIDINE HYDROCHLORIDE","activeIngredients":"TIZANIDINE HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-01-26
)
)