Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021225

MIRENA (LEVONORGESTREL)
52MG
Marketing Status: Prescription
Active Ingredient: LEVONORGESTREL
Proprietary Name: MIRENA
Dosage Form; Route of Administration: INTRAUTERINE DEVICE; INTRAUTERINE
Strength: 52MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021225
Product Number: 001
Approval Date: Dec 6, 2000
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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