Details for New Drug Application (NDA): 211713
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NDA 211713 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Qilu Pharm Hainan, Xellia Pharms Aps, and Zydus Pharms, and is included in nine NDAs. It is available from eleven 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 211713
| Tradename: | MICAFUNGIN SODIUM |
| Applicant: | Xellia Pharms Aps |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211713
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 211713 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-036 | 70594-036-01 | 1 VIAL, GLASS in 1 CARTON (70594-036-01) / 5 mL in 1 VIAL, GLASS |
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 211713 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-037 | 70594-037-01 | 1 VIAL, GLASS in 1 CARTON (70594-037-01) / 5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Jun 2, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Jun 2, 2021 | TE: | AP | RLD: | No | ||||
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