Application Sponsors
| ANDA 202001 | TORRENT PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 500MG;EQ 15MG BASE | 0 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 850MG;EQ 15MG BASE | 0 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2013-02-13 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2020-02-21 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TORRENT PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202001
[companyName] => TORRENT PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"500MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"850MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/21\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-21
)
)