Details for New Drug Application (NDA): 017648
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NDA 017648 describes SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%, which is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs. It is available from one supplier. Additional details are available on the SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
Summary for 017648
| Tradename: | SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% |
| Applicant: | Baxter Hlthcare |
| Ingredient: | potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 017648
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 017648
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 017648 | NDA | Baxter Healthcare Corporation | 0338-0691 | 0338-0691-04 | 14 BAG in 1 CARTON (0338-0691-04) / 1000 mL in 1 BAG |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 017648 | NDA | Baxter Healthcare Corporation | 0338-0691 | 0338-0691-04 | 14 BAG in 1 CARTON (0338-0691-04) / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 150MG/100ML;900MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/100ML;900MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 224MG/100ML;900MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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