Details for New Drug Application (NDA): 216438
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NDA 216438 describes MICAFUNGIN SODIUM, which is a drug marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms, and is included in eight 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 216438
| Tradename: | MICAFUNGIN SODIUM |
| Applicant: | Biocon Pharma |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 216438 | ANDA | Biocon Pharma Inc. | 70377-075 | 70377-075-91 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70377-075-91) / 5 mL in 1 VIAL, SINGLE-DOSE |
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 216438 | ANDA | Biocon Pharma Inc. | 70377-076 | 70377-076-91 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70377-076-91) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | May 29, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | May 29, 2024 | TE: | AP | RLD: | No | ||||
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