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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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for NDA: 020866

Tradename:
CYCLOSET
Applicant:
Veroscience
Ingredient:
bromocriptine mesylate
Patents:8
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020866

Ingredient-typeErgolines

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.8MG BASE
Approval Date:May 5, 2009TE:RLD:Yes
Patent:8,431,155Patent Expiration:Apr 30, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
Patent:8,613,947Patent Expiration:Apr 30, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
Patent:9,192,576Patent Expiration:Apr 30, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES

Expired Orange Book 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;ORAL020866-001May 5, 20095,468,755► subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,756,513► subscribe
Veroscience
CYCLOSET
bromocriptine mesylate
TABLET;ORAL020866-001May 5, 20095,866,584► subscribe
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