Application 207320
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REGADENOSON | REGADENOSON | SOLUTION;INTRAVENOUS | 0.4MG/5ML (0.08MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-175 | Regadenoson | Regadenoson | Gland Pharma Limited | ANDA | Current |