Details for New Drug Application (NDA): 021572
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The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-six 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 |
Formulation / Manufacturing: | see details |
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 | 67919-011 | 67919-011-01 | 1 VIAL, SINGLE-USE in 1 CARTON (67919-011-01) / 10 mL in 1 VIAL, SINGLE-USE |
CUBICIN RF | daptomycin | POWDER;INTRAVENOUS | 021572 | NDA | Merck Sharp & Dohme LLC | 67919-011 | 67919-011-01 | 1 VIAL, SINGLE-USE in 1 CARTON (67919-011-01) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 250MG/VIAL | ||||
Approval Date: | Sep 12, 2003 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Sep 12, 2003 | TE: | AP | RLD: | Yes | ||||
Patent: | ⤷ Try a Trial | 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 | ||||
Approval Date: | Jul 6, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 021572
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