Application 205060
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPANOVA | OMEGA-3-CARBOXYLIC ACIDS | CAPSULE;ORAL | 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47548 | SUPPL | 2017-03-14 |
| 47521 | SUPPL | 2017-03-10 |
| 46928 | SUPPL | 2017-01-23 |
| 45608 | SUPPL | 2016-10-12 |
| 45524 | SUPPL | 2016-10-12 |
| 43483 | ORIG | 2016-03-28 |
| 32624 | ORIG | 2014-05-06 |
| 19618 | ORIG | 2014-05-06 |