Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 2MG;30MG | 0 | PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 4MG;30MG | 0 | PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE | GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-01-04 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-07-23 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-02-24 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-02-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SANDOZ
cder:Array
(
[0] => Array
(
[ApplNo] => 201049
[companyName] => SANDOZ
[docInserts] => ["",""]
[products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"2MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"4MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/04\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/24\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/02\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-24
)
)