Details for New Drug Application (NDA): 018803
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NDA 018803 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Baxter Hlthcare, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-three 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 018803
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Hospira |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 018803
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 018803
| 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 | 018803 | NDA | Henry Schein, Inc. | 0404-9954 | 0404-9954-20 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 018803 | NDA | Henry Schein, Inc. | 0404-9954 | 0404-9954-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-50) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 90MG/10ML (9MG/ML) | ||||
| Approval Date: | Oct 29, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 180MG/20ML (9MG/ML) | ||||
| Approval Date: | Oct 29, 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: | Oct 29, 1982 | TE: | AP | RLD: | Yes | ||||
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