Details for New Drug Application (NDA): 216142
✉ Email this page to a colleague
NDA 216142 describes MICAFUNGIN IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the MICAFUNGIN IN SODIUM CHLORIDE 0.9% profile page.
The generic ingredient in MICAFUNGIN IN SODIUM CHLORIDE 0.9% 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 IN SODIUM CHLORIDE 0.9% 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 216142
| Tradename: | MICAFUNGIN IN SODIUM CHLORIDE 0.9% |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | micafungin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216142
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | micafungin sodium | SOLUTION;INTRAVENOUS | 216142 | NDA | Baxter Healthcare Corporation | 0338-9051 | 0338-9051-12 | 12 CARTON in 1 CARTON (0338-9051-12) / 1 BAG in 1 CARTON (0338-9051-01) / 50 mL in 1 BAG |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | micafungin sodium | SOLUTION;INTRAVENOUS | 216142 | NDA | Baxter Healthcare Corporation | 0338-9053 | 0338-9053-12 | 12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 50MG BASE/50ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Sep 29, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 100MG BASE/100ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Sep 29, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 150MG BASE/150ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Sep 29, 2023 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
