Details for New Drug Application (NDA): 219273
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NDA 219273 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Aspiro, Biocon Pharma, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, Yichang Humanwell, and Zydus Pharms, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the MICAFUNGIN SODIUM profile page.
The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 219273
| Tradename: | MICAFUNGIN SODIUM |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219273
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 219273 | ANDA | Qilu Pharmaceutical Co., Ltd | 67184-0589 | 67184-0589-1 | 1 VIAL in 1 CARTON (67184-0589-1) / 5 mL in 1 VIAL |
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 219273 | ANDA | Qilu Pharmaceutical Co., Ltd | 67184-0589 | 67184-0589-2 | 10 VIAL in 1 CARTON (67184-0589-2) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Apr 3, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Apr 3, 2025 | TE: | AP | RLD: | No | ||||
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