Details for New Drug Application (NDA): 206005
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The generic ingredient in DAPTOMYCIN 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 206005
Tradename: | DAPTOMYCIN |
Applicant: | Xellia Pharms Aps |
Ingredient: | daptomycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 206005
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 206005 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-034 | 70594-034-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01) / 10 mL in 1 VIAL, SINGLE-USE |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 206005 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-034 | 70594-034-02 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-02) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Jun 15, 2016 | TE: | AP | RLD: | No |
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