Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203723

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ESTRADIOL VALERATE (ESTRADIOL VALERATE)
10MG/ML
Marketing Status: Prescription

Active Ingredient: ESTRADIOL VALERATE
Proprietary Name: ESTRADIOL VALERATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: A203723
Product Number: 001
Approval Date: Apr 21, 2020
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information

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: A203723
Product Number: 002
Approval Date: Apr 21, 2020
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
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: A203723
Product Number: 003
Approval Date: Apr 21, 2020
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information