Luvira
Omega-3-acid Dietary Supplement Dispense by Prescription
Approved
Approval ID
9f38aea7-4e56-42fc-99d6-c964a9f26205
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2020
Manufacturers
FDA
Sterling-Knight Pharmaceuticals, LLC
DUNS: 079556942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Luvira
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69336-349
Product Classification
G
Generic Name
Luvira
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2020
FDA Product Classification
INGREDIENTS (5)
OMEGA-3 FATTY ACIDSActive
Quantity: 1220 mg in 1 1
Code: 71M78END5S
Classification: ACTIB
4,7,10,13,16,19-DOCOSAHEXAENOIC ACID, (4E,7E,10E,13E,16E,19E)-Active
Quantity: 375 mg in 1 1
Code: ZR7NX0Z98X
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
12-HYDROXYEICOSAPENTAENOIC ACID, (12R)-Active
Quantity: 465 mg in 1 1
Code: 78P2ZC128S
Classification: ACTIB