Luvira

Luvira

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Sterling-Knight Pharmaceuticals, LLC

DUNS: 079556942

Effective Date

January 28, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Omega-3 fatty acids(1220 mg in 1 1)

4,7,10,13,16,19-docosahexaenoic acid, (4 e,7 e,10 e,13 e,16 e,19 e)-(375 mg in 1 1)

(12R)-12-hydroxyeicosapentaenoic acid(465 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Sterling-Knight Pharmaceuticals, LLC

Labeler

Sterling-Knight Pharmaceuticals, LLC

DUNS Number

079556942

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

69336-349

Route of Administration

ORAL

Effective Date

January 17, 2020

Ingredients

Omega-3 fatty acidsActive

Code: 71M78END5SClass: ACTIBQuantity: 1220 mg in 1 1

4,7,10,13,16,19-docosahexaenoic acid, (4 e,7 e,10 e,13 e,16 e,19 e)-Active

Code: ZR7NX0Z98XClass: ACTIBQuantity: 375 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

(12R)-12-hydroxyeicosapentaenoic acidActive

Code: 78P2ZC128SClass: ACTIBQuantity: 465 mg in 1 1

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Luvira

FDA Approval Summary

Manufacturing Establishments1

Products1

Luvira

Product Details