Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203752

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

Active Ingredient: ESTRADIOL
Proprietary Name: MINIVELLE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.025MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203752
Product Number: 005
Approval Date: Sep 23, 2014
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINIVELLE (ESTRADIOL)
0.0375MG/24HR Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: MINIVELLE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.0375MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203752
Product Number: 001
Approval Date: Oct 29, 2012
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINIVELLE (ESTRADIOL)
0.05MG/24HR Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: MINIVELLE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.05MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203752
Product Number: 003
Approval Date: Oct 29, 2012
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINIVELLE (ESTRADIOL)
0.075MG/24HR Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: MINIVELLE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.075MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N203752
Product Number: 002
Approval Date: Oct 29, 2012
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINIVELLE (ESTRADIOL)
0.1MG/24HR Marketing Status: Prescription

Active Ingredient: ESTRADIOL
Proprietary Name: MINIVELLE
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 0.1MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203752
Product Number: 004
Approval Date: Oct 29, 2012
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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