Application 213517
- Type
- ANDA
- Sponsor
- I3 PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANOLAZINE | RANOLAZINE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | RANOLAZINE | RANOLAZINE | TABLET, EXTENDED RELEASE;ORAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72319-021 | RANOLAZINE | RANOLAZINE | i3 Pharmaceuticals, LLC | ANDA | Current |
| 72319-021 | RANOLAZINE | RANOLAZINE | i3 Pharmaceuticals, LLC | ANDA | Current |
| 72319-022 | RANOLAZINE | RANOLAZINE | i3 Pharmaceuticals, LLC | ANDA | Current |
| 72319-022 | RANOLAZINE | RANOLAZINE | i3 Pharmaceuticals, LLC | ANDA | Current |