Details for New Drug Application (NDA): 206203
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NDA 206203 describes POTASSIUM ACETATE, which is a drug marketed by Exela Pharma and Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM ACETATE profile page.
The generic ingredient in POTASSIUM ACETATE is potassium acetate. There are two hundred and forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the potassium acetate profile page.
The generic ingredient in POTASSIUM ACETATE is potassium acetate. There are two hundred and forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the potassium acetate profile page.
Summary for 206203
| Tradename: | POTASSIUM ACETATE |
| Applicant: | Exela Pharma |
| Ingredient: | potassium acetate |
| Patents: | 0 |
Pharmacology for NDA: 206203
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 206203
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM ACETATE | potassium acetate | INJECTABLE;INJECTION | 206203 | ANDA | Exela Pharma Sciences, LLC | 51754-2001 | 51754-2001-4 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-2001-4) / 20 mL in 1 VIAL, SINGLE-DOSE |
| POTASSIUM ACETATE | potassium acetate | INJECTABLE;INJECTION | 206203 | ANDA | Exela Pharma Sciences, LLC | 51754-2004 | 51754-2004-4 | 25 VIAL, GLASS in 1 CARTON (51754-2004-4) / 100 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MEQ/ML | ||||
| Approval Date: | Dec 29, 2015 | TE: | AP | RLD: | No | ||||
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