Omega-3-Acid Ethyl Esters

Product NDC
70518-2319
11-digit product format
705182319
Labeler code
70518
Product ID
70518-2319_b96d75f4-c073-f2ee-e053-2a95a90aa63f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omega-3-Acid Ethyl Esters
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204940
Marketing category
ANDA
Marketing start
2019-09-20
Marketing end
0000-00-00
Substance
OMEGA-3-ACID ETHYL ESTERS
Active strength
1 g/1
Pharmacologic classes
Fatty Acids, Omega-3 [CS],Omega-3 Fatty Acid [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record