Application 208999
- Type
- ANDA
- Sponsor
- SUNSHINE LAKE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG | No | No |
| 003 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48792-7861 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7862 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |
| 48792-7863 | Metformin Hydrochloride | Metformin Hydrochloride | Sunshine Lake Pharma Co., Ltd. | ANDA | Current |