Details for New Drug Application (NDA): 212513
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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 212513
Tradename: | DAPTOMYCIN |
Applicant: | Be Pharms |
Ingredient: | daptomycin |
Patents: | 0 |
Suppliers and Packaging for NDA: 212513
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 212513 | ANDA | Camber Pharmaceuticals Inc. | 31722-102 | 31722-102-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-102-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 212513 | ANDA | Cipla USA Inc. | 69097-807 | 69097-807-37 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-807-37) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Jun 26, 2019 | TE: | AP | RLD: | No |
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