Details for New Drug Application (NDA): 016677
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NDA 016677 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Laboratorios Grifols, Liebel-flarsheim, Abbott, Baxter Hlthcare, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-one suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 016677
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 016677
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 016677
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 016677 | NDA | Baxter Healthcare Corporation | 0338-0049 | 0338-0049-02 | 250 mL in 1 BAG (0338-0049-02) |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 016677 | NDA | Baxter Healthcare Corporation | 0338-0049 | 0338-0049-03 | 500 mL in 1 BAG (0338-0049-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 450MG/50ML (9MG/ML) | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 225MG/25ML (9MG/ML) | ||||
| Approval Date: | Oct 30, 1985 | TE: | RLD: | Yes | |||||
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