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Details for New Drug Application (NDA): 019635
NDA 019635 describes SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Baxter Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the SODIUM CHLORIDE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in SODIUM CHLORIDE 5% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
The generic ingredient in SODIUM CHLORIDE 5% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 019635
| Tradename: | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER |
| Applicant: | B Braun |
| Ingredient: | sodium chloride |
| Patents: | 0 |
| Therapeutic Class: | Therapeutic Nutrients/Minerals/Electrolytes |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019635
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 019635 | NDA | B. Braun Medical Inc. | 0264-7800 | N | 0264-7800-00 |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 019635 | NDA | B. Braun Medical Inc. | 0264-7800 | N | 0264-7800-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 450MG/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3GM/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | No | ||||
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