Application 202057
- Type
- NDA
- Sponsor
- AMARIN PHARMS
Application Products
| 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 | 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 |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|
| 61327 | 0 | SUPPL | 35 | 2019-12-17 |
| 61277 | 0 | SUPPL | 35 | 2019-12-16 |
| 47263 | 0 | SUPPL | 19 | 2017-02-17 |
| 40106 | 0 | SUPPL | 12 | 2015-06-24 |
| 40104 | 0 | SUPPL | 6 | 2014-02-14 |
| 32162 | 0 | SUPPL | 6 | 2014-02-14 |
| 32163 | 0 | SUPPL | 9 | 2013-11-27 |
| 40105 | 0 | SUPPL | 9 | 2013-11-26 |
| 40103 | 0 | SUPPL | 2 | 2013-03-26 |
| 44841 | 0 | ORIG | 1 | 2013-03-06 |
| 43379 | 0 | ORIG | 1 | 2013-03-06 |
| 32161 | 0 | SUPPL | 1 | 2013-02-04 |
| 32160 | 0 | ORIG | 1 | 2012-07-30 |
| 19048 | 0 | ORIG | 1 | 2012-07-30 |