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Application 202057
- Type
- NDA
- Sponsor
- AMARIN PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VASCEPA | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | Yes | Yes |
| 002 | VASCEPA | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-001 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-003 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 52937-101 | Vascepa | icosapent ethyl | Amarin Pharma Inc. | NDA | Current |
| 63629-8247 | Vascepa | icosapent ethyl | Bryant Ranch Prepack | NDA | Current |
| 63629-8247 | Vascepa | icosapent ethyl | Bryant Ranch Prepack | NDA | Current |