Details for New Drug Application (NDA): 217630
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NDA 217630 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 217630
| Tradename: | DAPTOMYCIN |
| Applicant: | Maia Pharms Inc |
| Ingredient: | daptomycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217630
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 217630 | NDA | Par Health USA, LLC | 42023-295 | 42023-295-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01) |
| DAPTOMYCIN | daptomycin | POWDER;INTRAVENOUS | 217630 | NDA | MAIA Pharmaceuticals, Inc. | 70511-182 | 70511-182-84 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70511-182-84) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70511-182-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 350MG/VIAL | ||||
| Approval Date: | Nov 21, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL | ||||
| Approval Date: | Nov 21, 2024 | TE: | RLD: | Yes | |||||
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