Details for New Drug Application (NDA): 210282
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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 210282
Tradename: | DAPTOMYCIN |
Applicant: | Hospira |
Ingredient: | daptomycin |
Patents: | 2 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210282
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 210282 | NDA | Hospira, Inc. | 0409-0120 | 0409-0120-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0120-01) / 7 mL in 1 VIAL, SINGLE-DOSE |
DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 210282 | NDA | Hospira, Inc. | 0409-0122 | 0409-0122-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
Approval Date: | Jun 21, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND S. AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY RECONSTITUTING AND ADMINISTERING THE FORMULATION AS RECITED IN CLAIM 12 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY ADMINISTERING THE FORMULATION OF DAPTOMYCIN AS RECITED IN CLAIM 18 |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Jun 21, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 11, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND S. AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY RECONSTITUTING AND ADMINISTERING THE FORMULATION AS RECITED IN CLAIM 12 |
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