Details for New Drug Application (NDA): 202495
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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. Thirteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
Summary for 202495
Tradename: | SODIUM BICARBONATE |
Applicant: | Hospira |
Ingredient: | sodium bicarbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202495
Mechanism of Action | Alkalinizing Activity Osmotic Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202495
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202495 | ANDA | Henry Schein, Inc. | 0404-9950 | 0404-9950-10 | 1 SYRINGE, GLASS in 1 BAG (0404-9950-10) / 10 mL in 1 SYRINGE, GLASS |
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202495 | ANDA | Hospira, Inc. | 0409-4900 | 0409-4900-14 | 10 CARTON in 1 PACKAGE (0409-4900-14) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE (0409-4900-24) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
Approval Date: | Mar 6, 2017 | TE: | RLD: | No |
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