Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020538

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

Active Ingredient: ESTRADIOL
Proprietary Name: VIVELLE-DOT
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.025MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N020538
Product Number: 009
Approval Date: May 3, 2002
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIVELLE-DOT (ESTRADIOL)
0.0375MG/24HR
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: VIVELLE-DOT
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.0375MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N020538
Product Number: 005
Approval Date: Jan 8, 1999
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIVELLE-DOT (ESTRADIOL)
0.05MG/24HR
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: VIVELLE-DOT
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.05MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N020538
Product Number: 006
Approval Date: Jan 8, 1999
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIVELLE-DOT (ESTRADIOL)
0.075MG/24HR
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: VIVELLE-DOT
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.075MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N020538
Product Number: 007
Approval Date: Jan 8, 1999
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VIVELLE-DOT (ESTRADIOL)
0.1MG/24HR
Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: VIVELLE-DOT
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 0.1MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N020538
Product Number: 008
Approval Date: Jan 8, 1999
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information