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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 fifty-four drug master file entries for this compound. Twenty-three 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 fifty-four drug master file entries for this compound. Twenty-three 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 |
| 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 | 0264-7800-01 | 10 CONTAINER in 1 CARTON (0264-7800-01) > 500 mL in 1 CONTAINER |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 019635 | NDA | B. Braun Medical Inc. | 0264-7800 | 0264-7800-90 | 10 CONTAINER in 1 CARTON (0264-7800-90) > 1000 mL in 1 CONTAINER |
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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