Details for New Drug Application (NDA): 215890
✉ Email this page to a colleague
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 215890
Tradename: | DAPTOMYCIN |
Applicant: | Hainan Poly Pharm |
Ingredient: | daptomycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 215890
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 215890 | ANDA | Hainan Poly Pharm., Co., Ltd. | 14335-120 | 14335-120-01 | 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01) |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 215890 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-033 | 70436-033-80 | 20 mL in 1 VIAL, SINGLE-DOSE (70436-033-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Aug 18, 2022 | TE: | AP | RLD: | No |
Complete Access Available with Subscription