Documents
Application Sponsors
| ANDA 204802 | MACLEODS 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
| UNKNOWN; | ORIG | 1 | AP | 2015-11-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2016-12-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-03-06 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204802
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"500MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"850MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/05\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204802Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/06\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/06\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/14\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-03-06
)
)