Details for New Drug Application (NDA): 088911
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NDA 088911 describes BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, and Hospira, and is included in three NDAs. It is available from five suppliers. Additional details are available on the BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in BACTERIOSTATIC 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 BACTERIOSTATIC 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 088911
| Tradename: | BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 088911
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 088911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 088911 | ANDA | Fresenius Kabi USA, LLC | 63323-924 | 63323-924-10 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-924-01) |
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 088911 | ANDA | Fresenius Kabi USA, LLC | 63323-924 | 63323-924-30 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-924-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 270MG/30ML (9MG/ML) | ||||
| Approval Date: | Feb 7, 1985 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 90MG/10ML (9MG/ML) | ||||
| Approval Date: | May 17, 1985 | TE: | AP | RLD: | No | ||||
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