Application 204934
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIACIN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | NIACIN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-187 | Niacin | Niacin | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-187 | Niacin | Niacin | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-189 | Niacin | Niacin | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-189 | Niacin | Niacin | Macleods Pharmaceuticals Limited | ANDA | Current |