Details for New Drug Application (NDA): 019465
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NDA 019465 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 019465
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Hospira |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 019465
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019465
| 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 | 019465 | NDA | Hospira, Inc. | 0409-7101 | 0409-7101-02 | 24 POUCH in 1 CASE (0409-7101-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7101-04) |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 019465 | NDA | Hospira, Inc. | 0409-7101 | 0409-7101-66 | 10 POUCH in 1 CASE (0409-7101-66) / 5 BAG in 1 POUCH / 50 mL in 1 BAG (0409-7101-68) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | Jul 15, 1985 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 450MG/50ML (9MG/ML) | ||||
| Approval Date: | Jul 15, 1985 | TE: | AP | RLD: | Yes | ||||
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