Details for New Drug Application (NDA): 208375
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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 208375
Tradename: | DAPTOMYCIN |
Applicant: | Dr Reddys |
Ingredient: | daptomycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208375
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 208375 | ANDA | NorthStar RxLLC | 16714-892 | 16714-892-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) / 15 mL in 1 VIAL, SINGLE-DOSE |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 208375 | ANDA | Dr.Reddy's Laboratories Inc., | 43598-413 | 43598-413-11 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-413-11) / 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: | May 1, 2019 | TE: | AP | RLD: | No |
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