Application Sponsors
| ANDA 203769 | SCIEGEN PHARMS INC | |
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
| UNKNOWN; | ORIG | 1 | AP | 2013-09-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2014-12-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-05-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 18 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 203769
[companyName] => SCIEGEN PHARMS INC
[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":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/11\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/05\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/22\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/22\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/02\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/20\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-05
)
)