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Generated: November 20, 2018

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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. Forty-six 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
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 0078-0343-45 3 BOX in 1 CARTON (0078-0343-45) > 8 POUCH in 1 BOX (0078-0343-42) > 1 PATCH in 1 POUCH (0078-0343-62) > 3.5 d in 1 PATCH
VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538 NDA Novartis Pharmaceuticals Corporation 0078-0344 0078-0344-45 3 BOX in 1 CARTON (0078-0344-45) > 8 POUCH in 1 BOX (0078-0344-42) > 1 PATCH in 1 POUCH (0078-0344-62) > 3.5 d in 1 PATCH

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 020538-007 Jan 8, 1999 ➤ Sign Up ➤ Sign Up
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999 ➤ Sign Up ➤ Sign Up
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-006 Jan 8, 1999 ➤ Sign Up ➤ Sign Up
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-009 May 3, 2002 ➤ Sign Up ➤ Sign Up
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-008 Jan 8, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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