Details for New Drug Application (NDA): 216142
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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. There is one patent protecting this drug. 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. Fourteen 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. Fourteen 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: | 1 |
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 | |||||
| Patent: | 12,403,173 | Patent Expiration: | Dec 15, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | |||||
| Patent: | 12,403,173 | Patent Expiration: | Dec 15, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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 | |||||
| Patent: | 12,403,173 | Patent Expiration: | Dec 15, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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