Application Sponsors
| ANDA 200958 | AUSTARPHARMA LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | METHOCARBAMOL | METHOCARBAMOL |
| 002 | TABLET;ORAL | 750MG | 0 | METHOCARBAMOL | METHOCARBAMOL |
| 003 | TABLET;ORAL | 1GM | 0 | METHOCARBAMOL | METHOCARBAMOL |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2011-10-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2022-07-15 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2022-10-12 | UNKNOWN |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 15 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
AUSTARPHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 200958
[companyName] => AUSTARPHARMA LLC
[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":"10\/21\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2011-10-21
)
)