Details for New Drug Application (NDA): 211087
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NDA 211087 describes POTASSIUM CHLORIDE 40MEQ, which is a drug marketed by Fresenius Kabi Usa, Nexus, Baxter Hlthcare, and Icu Medical Inc, and is included in sixteen NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 40MEQ profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ 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 POTASSIUM CHLORIDE 40MEQ 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 211087
| Tradename: | POTASSIUM CHLORIDE 40MEQ |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | potassium chloride |
| Patents: | 0 |
Pharmacology for NDA: 211087
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 211087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ | potassium chloride | INJECTABLE;INJECTION | 211087 | ANDA | Fresenius Kabi USA, LLC | 65219-004 | 65219-004-01 | 60 BAG in 1 CARTON (65219-004-01) / 50 mL in 1 BAG (65219-004-00) |
| POTASSIUM CHLORIDE 10MEQ | potassium chloride | INJECTABLE;INJECTION | 211087 | ANDA | Fresenius Kabi USA, LLC | 65219-006 | 65219-006-01 | 50 BAG in 1 CARTON (65219-006-01) / 100 mL in 1 BAG (65219-006-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 14.9MG/ML | ||||
| Approval Date: | Sep 9, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 746MG/100ML | ||||
| Approval Date: | Sep 9, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 29.8MG/ML | ||||
| Approval Date: | Sep 9, 2020 | TE: | AP | RLD: | No | ||||
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