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.
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 |
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: | See Plans and Pricing | Patent Expiration: | Apr 30, 2032 | Product 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 Pricing | Patent Expiration: | Apr 30, 2032 | Product 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 Pricing | Patent Expiration: | Apr 30, 2032 | Product 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | See Plans and Pricing | See Plans and Pricing |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | See Plans and Pricing | See Plans and Pricing |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | See Plans and Pricing | See Plans and Pricing |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | See Plans and Pricing | See Plans and Pricing |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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