Details for New Drug Application (NDA): 208385
✉ Email this page to a colleague
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 208385
Tradename: | DAPTOMYCIN |
Applicant: | Sagent Pharms Inc |
Ingredient: | daptomycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 208385 | NDA | Sagent Pharmaceuticals | 25021-179 | 25021-179-15 | 1 VIAL in 1 CARTON (25021-179-15) / 7 mL in 1 VIAL |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 208385 | NDA | Sagent Pharmaceuticals | 25021-179 | 25021-179-16 | 10 VIAL in 1 CARTON (25021-179-16) / 7 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
Approval Date: | Sep 12, 2017 | TE: | AP | RLD: | Yes |
Complete Access Available with Subscription