Details for New Drug Application (NDA): 215316
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NDA 215316 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 215316
| Tradename: | DAPTOMYCIN |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | daptomycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 215316 | ANDA | APOTEX CORP. | 60505-6229 | 60505-6229-4 | 1 VIAL, SINGLE-USE in 1 CARTON (60505-6229-4) / 10 mL in 1 VIAL, SINGLE-USE |
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 215316 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0549 | 67184-0549-1 | 1 VIAL, SINGLE-USE in 1 CARTON (67184-0549-1) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Aug 24, 2021 | TE: | AP | RLD: | No | ||||
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