Details for New Drug Application (NDA): 021572
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NDA 021572 describes CUBICIN RF, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CUBICIN RF profile page.
The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 021572
| Tradename: | CUBICIN RF |
| Applicant: | Cubist Pharms Llc |
| Ingredient: | daptomycin |
| Patents: | 2 |
Suppliers and Packaging for NDA: 021572
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572 | NDA | Merck Sharp & Dohme LLC | 67919-012 | 67919-012-01 | 1 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) / 10 mL in 1 VIAL, SINGLE-USE |
| CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572 | NDA | Merck Sharp & Dohme LLC | 67919-012 | 67919-012-01 | 1 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 12, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 12, 2003 | TE: | RLD: | Yes | |||||
| Patent: | 8,003,673 | Patent Expiration: | Sep 4, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 6, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 9,138,456 | Patent Expiration: | Nov 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 021572
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | 8,129,342 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-001 | Sep 12, 2003 | RE39071 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | 8,058,238 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-001 | Sep 12, 2003 | 5,912,226 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | 6,468,967 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | RE39071 | ⤷ Subscribe |
| Cubist Pharms Llc | CUBICIN | daptomycin | POWDER;INTRAVENOUS | 021572-002 | Sep 12, 2003 | 5,912,226 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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