You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 16, 2024

Details for New Drug Application (NDA): 020538

✉ Email this page to a colleague

« Back to Dashboard

NDA 020538 describes VIVELLE-DOT, which is a drug marketed by Sandoz 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-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.

Summary for 020538

Tradename:	VIVELLE-DOT
Applicant:	Sandoz
Ingredient:	estradiol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020538

Mechanism of Action	Estrogen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020538

Estrogens

Suppliers and Packaging for NDA: 020538

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538	NDA	Novartis Pharmaceuticals Corporation	0078-0343	0078-0343-42	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	SYSTEM;TRANSDERMAL	020538	NDA	Novartis Pharmaceuticals Corporation	0078-0344	0078-0344-42	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:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.0375MG/24HR
Approval Date:	Jan 8, 1999	TE:	AB1	RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.05MG/24HR
Approval Date:	Jan 8, 1999	TE:	AB1	RLD:	Yes

Profile for product number 007

Active Rx/OTC/Discontinued:	RX	Dosage:	SYSTEM;TRANSDERMAL			Strength	0.075MG/24HR
Approval Date:	Jan 8, 1999	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 020538

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.