Details for New Drug Application (NDA): 020538

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NDA 020538 describes VIVELLE-DOT, which is a drug marketed by Sandoz 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-nine 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

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-009	May 3, 2002	⤷ Sign Up	⤷ Sign Up
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999	⤷ Sign Up	⤷ Sign Up
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ Sign Up	⤷ Sign Up
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