Application Sponsors
| ANDA 209312 | GRANULES INDIA LTD | |
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 | 2018-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-07-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
GRANULES INDIA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209312
[companyName] => GRANULES INDIA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/14\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/14\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-14
)
)