Details for New Drug Application (NDA): 212156
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The generic ingredient in MICAFUNGIN 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 212156
Tradename: | MICAFUNGIN |
Applicant: | Par Sterile Products |
Ingredient: | micafungin sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 212156
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MICAFUNGIN | micafungin sodium | POWDER;INTRAVENOUS | 212156 | NDA | Par Pharmaceutical, Inc. | 42023-229 | 42023-229-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
MICAFUNGIN | micafungin sodium | POWDER;INTRAVENOUS | 212156 | NDA | Par Pharmaceutical, Inc. | 42023-230 | 42023-230-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-230-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
Approval Date: | Jun 16, 2021 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
Approval Date: | Jun 16, 2021 | TE: | RLD: | Yes |
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