Details for New Drug Application (NDA): 020866

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NDA 020866 describes CYCLOSET, which is a drug marketed by Veroscience and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the CYCLOSET profile page.

The generic ingredient in CYCLOSET is bromocriptine mesylate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for 020866

Tradename:	CYCLOSET
Applicant:	Veroscience
Ingredient:	bromocriptine mesylate
Patents:	13
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020866

Medical Subject Heading (MeSH) Categories for 020866

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

Suppliers and Packaging for NDA: 020866

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866	NDA	Santarus, Inc.	68012-258	68012-258-20	200 TABLET in 1 BOTTLE (68012-258-20)
CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866	NDA	Santarus, Inc.	68012-258	68012-258-21	21 TABLET in 1 BOTTLE (68012-258-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.8MG BASE
Approval Date:	May 5, 2009	TE:		RLD:	Yes
Patent:	Start Trial	Patent Expiration:	Jul 25, 2023	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
Patent:	Start Trial	Patent Expiration:	Jul 25, 2023	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
Patent:	Start Trial	Patent Expiration:	Jul 25, 2023	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS

Expired US Patents for NDA 020866

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	Start Trial	Start Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	Start Trial	Start Trial
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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