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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203159

SKYLA (LEVONORGESTREL)
13.5MG
Marketing Status: Prescription
Active Ingredient: LEVONORGESTREL
Proprietary Name: SKYLA
Dosage Form; Route of Administration: INTRAUTERINE DEVICE; INTRAUTERINE
Strength: 13.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203159
Product Number: 001
Approval Date: Jan 9, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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