Application Sponsors
| ANDA 202112 | INDOCO REMEDIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 1MG | 0 | GLIMEPIRIDE | GLIMEPIRIDE |
| 002 | TABLET;ORAL | 2MG | 0 | GLIMEPIRIDE | GLIMEPIRIDE |
| 003 | TABLET;ORAL | 4MG | 0 | GLIMEPIRIDE | GLIMEPIRIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-04-17 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2018-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-10-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
INDOCO REMEDIES
cder:Array
(
[0] => Array
(
[ApplNo] => 202112
[companyName] => INDOCO REMEDIES
[docInserts] => ["",""]
[products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/17\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/26\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-26
)
)