Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | BACLOFEN | BACLOFEN |
002 | TABLET;ORAL | 20MG | 0 | BACLOFEN | BACLOFEN |
003 | TABLET;ORAL | 5MG | 0 | BACLOFEN | BACLOFEN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-11-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
ZYDUS
cder:Array
(
[0] => Array
(
[ApplNo] => 211659
[companyName] => ZYDUS
[docInserts] => ["",""]
[products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-11-23
)
)