Details for New Drug Application (NDA): 201850
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NDA 201850 describes SODIUM CHLORIDE 0.9%, which is a drug marketed by Medefil Inc, B Braun, Hikma, Nexus Pharms, Spectra Mdcl Devices, Baxter Hlthcare, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Laboratorios Grifols, Liebel-flarsheim, Abbott, Jubilant Cadista, Miles, Nephron, and Taro, and is included in thirty-three NDAs. It is available from five suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% profile page.
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.
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 201850
| Tradename: | SODIUM CHLORIDE 0.9% |
| Applicant: | Hikma |
| Ingredient: | sodium chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201850
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 201850
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% | sodium chloride | SOLUTION;INJECTION | 201850 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-1512 | 0641-1512-36 | 100 AMPULE in 1 CARTON (0641-1512-36) / 10 mL in 1 AMPULE (0641-1512-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 90MG/10ML (9MG/ML) | ||||
| Approval Date: | Jan 20, 2012 | TE: | AP | RLD: | No | ||||
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