Details for New Drug Application (NDA): 018931
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NDA 018931 describes TRAVASOL 8.5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the TRAVASOL 8.5% IN PLASTIC CONTAINER profile page.
The generic ingredient in TRAVASOL 8.5% IN PLASTIC CONTAINER is amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.
The generic ingredient in TRAVASOL 8.5% IN PLASTIC CONTAINER is amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.
Summary for 018931
| Tradename: | TRAVASOL 8.5% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | amino acids |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRAVASOL 10% IN PLASTIC CONTAINER | amino acids | INJECTABLE;INJECTION | 018931 | NDA | Baxter Healthcare Corporation | 0338-0644 | 0338-0644-03 | 500 mL in 1 BAG (0338-0644-03) |
| TRAVASOL 10% IN PLASTIC CONTAINER | amino acids | INJECTABLE;INJECTION | 018931 | NDA | Baxter Healthcare Corporation | 0338-0644 | 0338-0644-04 | 1000 mL in 1 BAG (0338-0644-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5.5% (5.5GM/100ML) | ||||
| Approval Date: | Aug 23, 1984 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 8.5% (8.5GM/100ML) | ||||
| Approval Date: | Aug 23, 1984 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10% (10MG/100ML) | ||||
| Approval Date: | Aug 23, 1984 | TE: | RLD: | No | |||||
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