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VIVELLE-DOT Drug Profile

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Vivelle-dot is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers.

The generic ingredient in VIVELLE-DOT is estradiol. There are seventy-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: VIVELLE-DOT

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: VIVELLE-DOT

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: VIVELLE-DOT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002RXNo<disabled><disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999RXNo<disabled><disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999RXNo<disabled><disabled>
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Expired Patents for Tradename: VIVELLE-DOT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-008Jan 8, 19995,474,783<disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 19996,024,976<disabled>
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 19996,024,976<disabled>
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