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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
McKinsey
Healthtrust
Moodys
Queensland Health
Teva
Mallinckrodt
Farmers Insurance
Accenture
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Generated: September 25, 2017

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 four 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-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 020538

Tradename:
1
Applicant:
1
Ingredient:
1
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

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

Summary for product number 005

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

Summary for product number 006

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

Summary for product number 007

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

Expired Orange Book Patents for NDA: 020538

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-006Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-008Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 2002► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-005Jan 8, 1999► Subscribe► Subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 1999► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
McKinsey
Baxter
Medtronic
Dow
Chinese Patent Office
UBS
Harvard Business School
Johnson and Johnson
Mallinckrodt

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