Application 212504
- Type
- ANDA
- Sponsor
- GLW
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | CAPSULE;ORAL | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72998-850 | OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | KD Pharma USA, Inc. | ANDA | Current |