Orange Book product
OMEGA-3-ACID ETHYL ESTERS 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3…
Orange Book ANDA 212504 · GLW PHARMA GMBH · Prescription
Key facts
| Proprietary name | OMEGA-3-ACID ETHYL ESTERS |
|---|---|
| Active ingredients | OMEGA-3-ACID ETHYL ESTERS |
| Strength | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA212504 |
| Applicant holder | GLW PHARMA GMBH |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Aug 19, 2020 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.