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Details for New Drug Application (NDA): 020866
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. Eleven 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. Eleven 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
| Ingredient-type | Ergolines |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.8MG BASE | ||||
| Approval Date: | May 5, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | 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: | ➤ Sign Up | 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: | ➤ Sign Up | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | ➤ Sign Up | ➤ Sign Up |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | ➤ Sign Up | ➤ Sign Up |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | ➤ Sign Up | ➤ Sign Up |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | ➤ Sign Up | ➤ Sign Up |
| Veroscience | CYCLOSET | bromocriptine mesylate | TABLET;ORAL | 020866-001 | May 5, 2009 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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