Application 205330
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-141 | Metformin Hydrochloride | Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-141 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-142 | Metformin Hydrochloride | Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-142 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-143 | Metformin Hydrochloride | Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-143 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |