Details for New Drug Application (NDA): 202494
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NDA 202494 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Neocubes Pharma, Omnivium Pharms, Steriscience, and Abbott, and is included in fourteen NDAs. It is available from nineteen suppliers. Additional details are available on the SODIUM BICARBONATE profile page.
The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
Summary for 202494
| Tradename: | SODIUM BICARBONATE |
| Applicant: | Hospira |
| Ingredient: | sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 202494
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202494
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202494 | ANDA | Hospira, Inc. | 0409-6637 | 0409-6637-14 | 10 CARTON in 1 PACKAGE (0409-6637-14) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE (0409-6637-24) |
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202494 | ANDA | Medical Purchasing Solutions, LLC | 71872-7266 | 71872-7266-1 | 1 CARTON in 1 BAG (71872-7266-1) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.9MEQ/ML | ||||
| Approval Date: | Mar 6, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
| Approval Date: | Mar 6, 2017 | TE: | AP | RLD: | No | ||||
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