Details for New Drug Application (NDA): 212667
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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 212667
Tradename: | DAPTOMYCIN |
Applicant: | Accord Hlthcare |
Ingredient: | daptomycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 212667
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 212667 | ANDA | Accord Healthcare, Inc. | 16729-434 | 16729-434-05 | 1 VIAL in 1 CARTON (16729-434-05) / 7 mL in 1 VIAL |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 212667 | ANDA | Accord Healthcare, Inc. | 16729-434 | 16729-434-45 | 10 VIAL in 1 CARTON (16729-434-45) / 7 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
Approval Date: | Jul 12, 2019 | TE: | AP | RLD: | No |
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