Application 209156
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Related Records
Application Products
| 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 | 750MG | No | No |
| 003 | NIACIN | NIACIN | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-380 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-380 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-381 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-381 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-387 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-387 | niacin | Niacin | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |