Details for New Drug Application (NDA): 211713
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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 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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