Application Sponsors
| ANDA 203148 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | CAPSULE;ORAL | EQ 1.5MG BASE | 0 | RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE |
| 002 | CAPSULE;ORAL | EQ 3MG BASE | 0 | RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE |
| 003 | CAPSULE;ORAL | EQ 4.5MG BASE | 0 | RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE |
| 004 | CAPSULE;ORAL | EQ 6MG BASE | 0 | RIVASTIGMINE TARTRATE | RIVASTIGMINE TARTRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-08-22 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-07-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203148
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 1.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 3MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 4.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE TARTRATE","activeIngredients":"RIVASTIGMINE TARTRATE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/22\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/23\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-23
)
)