Application Sponsors
| ANDA 090564 | GRANULES INDIA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | 850MG | 0 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE |
| 003 | TABLET;ORAL | 1GM | 0 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-04-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2016-04-05 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2017-08-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-02-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
GRANULES INDIA
cder:Array
(
[0] => Array
(
[ApplNo] => 90564
[companyName] => GRANULES INDIA
[docInserts] => ["",""]
[products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"850MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)