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Last Updated: August 11, 2022

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 sixteen 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. Eight 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:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 020866
Medical Subject Heading (MeSH) Categories for 020866
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:RXDosage:TABLET;ORALStrengthEQ 0.8MG BASE
Approval Date:May 5, 2009TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Apr 30, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1 AND 2
Patent:See Plans and PricingPatent Expiration:Apr 30, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1 AND 2 AND 3
Patent:See Plans and PricingPatent Expiration:Apr 30, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 4 AND 5

Expired US Patents for NDA 020866

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Serving leading biopharmaceutical companies globally:

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