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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075182

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ESTRADIOL (ESTRADIOL)
0.025MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.025MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A075182
Product Number: 003
Approval Date: Jan 26, 2005
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL (ESTRADIOL)
0.0375MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.0375MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A075182
Product Number: 004
Approval Date: Jul 20, 2006
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL (ESTRADIOL)
0.05MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.05MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A075182
Product Number: 006
Approval Date: Feb 24, 2000
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL (ESTRADIOL)
0.06MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.06MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075182
Product Number: 005
Approval Date: Jul 20, 2006
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL (ESTRADIOL)
0.075MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.075MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A075182
Product Number: 002
Approval Date: Jan 26, 2005
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ESTRADIOL (ESTRADIOL)
0.1MG/24HR
Marketing Status: Prescription
Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.1MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A075182
Product Number: 001
Approval Date: Feb 24, 2000
Applicant Holder Full Name: MYLAN TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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