Active Ingredient: LEVONORGESTREL
Proprietary Name: KYLEENA
Dosage Form; Route of Administration: SYSTEM; INTRAUTERINE
Strength: 19.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208224
Product Number: 001
Approval Date: Sep 16, 2016
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:
Prescription
Patent and Exclusivity Information
