Details for New Drug Application (NDA): 207104
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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 207104
Tradename: | DAPTOMYCIN |
Applicant: | Sagent Pharms Inc |
Ingredient: | daptomycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 207104
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 207104 | ANDA | Sagent Pharmaceuticals | 25021-174 | 25021-174-15 | 1 VIAL in 1 CARTON (25021-174-15) / 10 mL in 1 VIAL |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 207104 | ANDA | Sagent Pharmaceuticals | 25021-174 | 25021-174-16 | 10 VIAL in 1 CARTON (25021-174-16) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Nov 15, 2019 | TE: | AP | RLD: | No |
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