Application Sponsors
| ANDA 091298 | TORRENT PHARMS LTD | |
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
| ORIG | 1 | AP | 2013-02-13 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-11-27 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-11-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
TORRENT PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 91298
[companyName] => TORRENT PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PIOGLITAZONE HYDROCHLORIDE","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)