Manufacturing Establishments4
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bayer Schering Pharma Oy
Bayer HealthCare Pharmaceuticals Inc.
369758383
Sharp Corporation
Bayer HealthCare Pharmaceuticals Inc.
143696495
Bayer AG
Bayer HealthCare Pharmaceuticals Inc.
342872971
Sterigenics Belgium Petit-Rechain S.A.
Bayer HealthCare Pharmaceuticals Inc.
370026481
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kyleena
Product Details
NDC Product Code
50419-424Application Number
NDA208224Marketing Category
NDA (C73594)Route of Administration
INTRAUTERINEEffective Date
March 1, 2018LevonorgestrelActive
Code: 5W7SIA7YZWClass: ACTIBQuantity: 19.5 mg in 1 1
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
BARIUM SULFATEInactive
Code: 25BB7EKE2EClass: IACT