Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211293

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ESTRADIOL (ESTRADIOL)
0.025MG/24HR
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: ESTRADIOL
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.025MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211293
Product Number: 001
Approval Date: Feb 4, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
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: SYSTEM; TRANSDERMAL
Strength: 0.0375MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211293
Product Number: 002
Approval Date: Feb 4, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
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: SYSTEM; TRANSDERMAL
Strength: 0.05MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211293
Product Number: 003
Approval Date: Feb 4, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
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: SYSTEM; TRANSDERMAL
Strength: 0.075MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211293
Product Number: 004
Approval Date: Feb 4, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
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: SYSTEM; TRANSDERMAL
Strength: 0.1MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211293
Product Number: 005
Approval Date: Feb 4, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information