Details for New Drug Application (NDA): 201833
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The generic ingredient in SODIUM CHLORIDE 0.9% is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.
Summary for 201833
Tradename: | SODIUM CHLORIDE 0.9% |
Applicant: | Hikma |
Ingredient: | sodium chloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201833
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 201833
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% | sodium chloride | SOLUTION;INJECTION | 201833 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-0497 | 0641-0497-25 | 25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17) |
SODIUM CHLORIDE 0.9% | sodium chloride | SOLUTION;INJECTION | 201833 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6144 | 0641-6144-25 | 25 VIAL in 1 CARTON (0641-6144-25) / 10 mL in 1 VIAL (0641-6144-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 18MG/2ML (9MG/ML) | ||||
Approval Date: | Sep 24, 2013 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 90MG/10ML (9MG/ML) | ||||
Approval Date: | Jan 7, 2015 | TE: | AP | RLD: | No |
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