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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021258

CLIMARA PRO (ESTRADIOL; LEVONORGESTREL)
0.045MG/24HR;0.015MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL; LEVONORGESTREL
Proprietary Name: CLIMARA PRO
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.045MG/24HR;0.015MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021258
Product Number: 001
Approval Date: Nov 21, 2003
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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