Details for New Drug Application (NDA): 088912
✉ Email this page to a colleague
NDA 088912 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 088912
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 088912
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 088912
| 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 | 088912 | ANDA | Henry Schein, Inc. | 0404-9955 | 0404-9955-10 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9955-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 088912 | ANDA | Cardinal Health 107, LLC | 55154-9357 | 55154-9357-5 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9357-5) / 10 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: | Jan 10, 1985 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 180MG/20ML (9MG/ML) | ||||
| Approval Date: | Jan 10, 1985 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 270MG/30ML (9MG/ML) | ||||
| Approval Date: | Jan 10, 1985 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
