Details for New Drug Application (NDA): 213363
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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 213363
| Tradename: | MICAFUNGIN SODIUM |
| Applicant: | Jiangsu Hansoh Pharm |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213363
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 213363 | ANDA | Sagent Pharmaceuticals | 25021-190 | 25021-190-10 | 1 VIAL in 1 CARTON (25021-190-10) / 5 mL in 1 VIAL |
| MICAFUNGIN SODIUM | micafungin sodium | INJECTABLE;INTRAVENOUS | 213363 | ANDA | Sagent Pharmaceuticals | 25021-190 | 25021-190-11 | 10 VIAL in 1 CARTON (25021-190-11) / 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: | Jul 9, 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: | Jul 9, 2021 | TE: | AP | RLD: | No | ||||
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