Details for New Drug Application (NDA): 210282
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NDA 210282 describes DAPTOMYCIN, which is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hikma, Hisun Pharm Hangzhou, Hospira, Maia Pharms Inc, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in thirty-one NDAs. It is available from twenty-seven suppliers. There are four patents protecting this drug. Additional details are available on the DAPTOMYCIN profile page.
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.
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 210282
| Tradename: | DAPTOMYCIN |
| Applicant: | Hospira |
| Ingredient: | daptomycin |
| Patents: | 2 |
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: | 10,357,535 | 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: | 9,655,946 | 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: | 10,357,535 | 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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