Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090920

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ESTRADIOL VALERATE (ESTRADIOL VALERATE)
20MG/ML
Marketing Status: Prescription
Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: ESTRADIOL VALERATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: A090920
Product Number: 001
Approval Date: Jan 19, 2010
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL VALERATE (ESTRADIOL VALERATE)
40MG/ML
Marketing Status: Prescription
Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: ESTRADIOL VALERATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: A090920
Product Number: 002
Approval Date: Jan 19, 2010
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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