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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021355

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ANGELIQ (DROSPIRENONE; ESTRADIOL)
0.25MG;0.5MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE; ESTRADIOL
Proprietary Name: ANGELIQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG;0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021355
Product Number: 001
Approval Date: Feb 29, 2012
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ANGELIQ (DROSPIRENONE; ESTRADIOL)
0.5MG;1MG
Marketing Status: Prescription
Active Ingredient: DROSPIRENONE; ESTRADIOL
Proprietary Name: ANGELIQ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG;1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021355
Product Number: 002
Approval Date: Sep 28, 2005
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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