Details for New Drug Application (NDA): 217415
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NDA 217415 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, Hisun Pharm Hangzhou, Hospira, 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 NDAs. It is available from twenty-six 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 217415
| Tradename: | DAPTOMYCIN |
| Applicant: | Xellia Pharms Aps |
| Ingredient: | daptomycin |
| Patents: | 2 |
Suppliers and Packaging for NDA: 217415
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 217415 | NDA | Xellia Pharmaceuticals USA LLC | 70594-060 | 70594-060-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-060-01) / 10 mL in 1 VIAL, SINGLE-USE |
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 217415 | NDA | Xellia Pharmaceuticals USA LLC | 70594-066 | 70594-066-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70594-066-01) / 7 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
| Approval Date: | Jan 30, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 28, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 28, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOOD STREAM INFECTIONS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Jan 30, 2023 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 28, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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