Application Sponsors
ANDA 208507 | BEXIMCO PHARMS USA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 500MG | 0 | METHOCARBAMOL | METHOCARBAMOL |
002 | TABLET;ORAL | 750MG | 0 | METHOCARBAMOL | METHOCARBAMOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-07-21 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
BEXIMCO PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 208507
[companyName] => BEXIMCO PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-07-21
)
)