Application Sponsors
| ANDA 078596 | AMNEAL PHARMS NY | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 750MG | 0 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2008-01-03 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-05-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2012-09-19 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-08-27 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 17 | Null | 15 |
TE Codes
| 001 | Prescription | AB1 |
| 002 | Prescription | AB |
CDER Filings
AMNEAL PHARMS NY
cder:Array
(
[0] => Array
(
[ApplNo] => 78596
[companyName] => AMNEAL PHARMS NY
[docInserts] => ["",""]
[products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)