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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-eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the estradiol profile page.

Summary for NDA: 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

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:No

Summary for product number 006

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Jan 8, 1999TE:AB1RLD:No

Summary for product number 007

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.075MG/24HR
Approval Date:Jan 8, 1999TE:AB1RLD:No

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;TRANSDERMAL020538-006Jan 8, 19995,958,446► subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-007Jan 8, 19995,958,446► subscribe
Novartis
VIVELLE-DOT
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020538-009May 3, 20025,474,783► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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