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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020538

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NDA 020538 describes VIVELLE-DOT, which is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. Additional details are available on the VIVELLE-DOT profile page.

The generic ingredient in VIVELLE-DOT is estradiol. There are seventy-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Summary for 020538
Tradename:VIVELLE-DOT
Applicant:Novartis
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 020538
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 020538
Suppliers and Packaging for NDA: 020538
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538 NDA Novartis Pharmaceuticals Corporation 0078-0343 N 0078-0343-45
VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538 NDA Novartis Pharmaceuticals Corporation 0078-0344 N 0078-0344-45

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Jan 8, 1999TE:AB1RLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Jan 8, 1999TE:AB1RLD:Yes

Profile for product number 007

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Jan 8, 1999TE:AB1RLD:Yes

Expired US Patents for NDA 020538

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-006 Jan 8, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-005 Jan 8, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-009 May 3, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
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US Department of Justice
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Federal Trade Commission
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