Application 209437
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-4033 | Icosapent Ethyl | Icosapent Ethyl | Apotex Corp | ANDA | Current |
| 60505-4033 | Icosapent Ethyl | Icosapent Ethyl | Apotex Corp | ANDA | Current |