Details for New Drug Application (NDA): 209949
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The generic ingredient in DAPTOMYCIN is daptomycin. There are ten drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 209949
Tradename: | DAPTOMYCIN |
Applicant: | Xellia Pharms Aps |
Ingredient: | daptomycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209949
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 209949 | NDA | Xellia Pharmaceuticals USA LLC | 70594-053 | 70594-053-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-053-01) / 7 mL in 1 VIAL, SINGLE-USE |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 209949 | NDA | Civica, Inc. | 72572-100 | 72572-100-01 | 1 VIAL, SINGLE-USE in 1 CARTON (72572-100-01) / 7 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
Approval Date: | Oct 20, 2017 | TE: | RLD: | Yes |
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