Application 209457
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No |
| 002 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0508 | Icosapent Ethyl | Icosapent Ethyl | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 63629-9311 | Icosapent Ethyl | Icosapent Ethyl | Bryant Ranch Prepack | ANDA | Current |
| 63629-9311 | Icosapent Ethyl | Icosapent Ethyl | Bryant Ranch Prepack | ANDA | Current |
| 72603-129 | Icosapent Ethyl | Icosapent Ethyl | Northstar Rx LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63418 | ORIG | 2020-06-04 |