Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208224

KYLEENA (LEVONORGESTREL)
19.5MG
Marketing Status: Prescription
Active Ingredient: LEVONORGESTREL
Proprietary Name: KYLEENA
Dosage Form; Route of Administration: INTRAUTERINE DEVICE; 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

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