Details for New Drug Application (NDA): 202832
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NDA 202832 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 202832
| Tradename: | SODIUM CHLORIDE 0.9% |
| Applicant: | Medefil Inc |
| Ingredient: | sodium chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202832
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% | sodium chloride | INJECTABLE;INJECTION | 202832 | NDA | Medefil, Inc. | 64253-202 | 64253-202-30 | 60 SYRINGE, PLASTIC in 1 BOX (64253-202-30) / 10 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 9MG/ML (9MG/ML) | ||||
| Approval Date: | Jan 6, 2012 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 18MG/2ML (9MG/ML) | ||||
| Approval Date: | Jan 6, 2012 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 22.5MG/2.5ML (9MG/ML) | ||||
| Approval Date: | Jan 6, 2012 | TE: | RLD: | Yes | |||||
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