Application Sponsors
ANDA 209331 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | SOLUTION;IM-IV | 1GM/10ML (100MG/ML) | 0 | METHOCARBAMOL | METHOCARBAMOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-04-17 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 209331
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;IM-IV","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-04-17
)
)