Details for New Drug Application (NDA): 019635
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NDA 019635 describes SODIUM CHLORIDE 0.9%, which is a drug marketed by Medefil Inc, B Braun, Hikma, Nexus, Spectra Mdcl Devices, Baxter Hlthcare, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro, and is included in thirty-four NDAs. It is available from four 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 019635
| Tradename: | SODIUM CHLORIDE 0.9% |
| Applicant: | B Braun |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 019635
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 019635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 019635 | NDA | B. Braun Medical Inc. | 0264-5802 | 0264-5802-00 | 12 CONTAINER in 1 CASE (0264-5802-00) / 1000 mL in 1 CONTAINER |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 019635 | NDA | B. Braun Medical Inc. | 0264-5802 | 0264-5802-10 | 24 CONTAINER in 1 CASE (0264-5802-10) / 500 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 450MG/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3GM/100ML | ||||
| Approval Date: | Mar 9, 1988 | TE: | AP | RLD: | No | ||||
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