Application 204977
- Type
- NDA
- Sponsor
- OSMOTICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMTRYG | OMEGA-3-ACID ETHYL ESTERS TYPE A | CAPSULE;ORAL | 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61112-001 | Omtryg | omega-3-acid ethyl esters | Trygg Pharma Inc | NDA | Current |