Application 076378
- Type
- ANDA
- Sponsor
- BARR
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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-584 | Niacin | Niacin | AvKARE, Inc. | ANDA | Current |
| 68151-6840 | Niacin | Niacin | Carilion Materials Management | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31114 | ORIG | 2005-04-28 |