Application Sponsors
| ANDA 202456 | ZYDUS PHARMS USA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 15MG BASE | 0 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 30MG BASE | 0 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | EQ 45MG BASE | 0 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-02-13 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-11-26 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-11-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202456
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/26\/2018","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-26
)
)