Details for New Drug Application (NDA): 216413
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NDA 216413 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-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-seven 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-seven suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 216413
| Tradename: | DAPTOMYCIN |
| Applicant: | Aspiro |
| Ingredient: | daptomycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216413
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 216413 | ANDA | Camber Pharmaceuticals, Inc. | 31722-216 | 31722-216-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-216-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 216413 | ANDA | NorthStar RxLLC | 72603-152 | 72603-152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-152-01) / 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: | Sep 23, 2022 | TE: | AP | RLD: | No | ||||
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