Application 206955
- 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, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-239 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-239 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-239 | Metformin Hydrochloride | Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-240 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-240 | Metformin hydrochloride | Metformin hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-240 | Metformin Hydrochloride | Metformin Hydrochloride | Macleods Pharmaceuticals Limited | ANDA | Current |
| 68071-4153 | Metformin Hydrochloride | Metformin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |