Details for New Drug Application (NDA): 020161
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NDA 020161 describes POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.
The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.
Summary for 020161
| Tradename: | POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | potassium chloride |
| Patents: | 0 |
Pharmacology for NDA: 020161
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 020161
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | potassium chloride | INJECTABLE;INJECTION | 020161 | NDA | ICU Medical Inc. | 0990-7074 | 0990-7074-26 | 24 POUCH in 1 CASE (0990-7074-26) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | potassium chloride | INJECTABLE;INJECTION | 020161 | NDA | ICU Medical Inc. | 0990-7074 | 0990-7074-26 | 24 POUCH in 1 CASE (0990-7074-26) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 745MG/100ML | ||||
| Approval Date: | Nov 30, 1992 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.49GM/100ML | ||||
| Approval Date: | Nov 30, 1992 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 2.24GM/100ML | ||||
| Approval Date: | Aug 11, 1998 | TE: | RLD: | Yes | |||||
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