Details for New Drug Application (NDA): 202981
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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 202981
Tradename: | SODIUM BICARBONATE |
Applicant: | Hospira |
Ingredient: | sodium bicarbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202981
Mechanism of Action | Osmotic Activity Alkalinizing Activity |
Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202981
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202981 | ANDA | Henry Schein, Inc. | 0404-9951 | 0404-9951-05 | 1 VIAL, SINGLE-USE in 1 BAG (0404-9951-05) / 5 mL in 1 VIAL, SINGLE-USE |
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202981 | ANDA | Hospira, Inc. | 0409-5555 | 0409-5555-02 | 25 VIAL, SINGLE-USE in 1 TRAY (0409-5555-02) / 5 mL in 1 VIAL, SINGLE-USE (0409-5555-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MEQ/ML | ||||
Approval Date: | Mar 4, 2016 | TE: | AP | RLD: | No |
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