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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022252

NATAZIA (DIENOGEST; ESTRADIOL VALERATE)
N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
Marketing Status: Prescription
Active Ingredient: DIENOGEST; ESTRADIOL VALERATE
Proprietary Name: NATAZIA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022252
Product Number: 001
Approval Date: May 6, 2010
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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