Details for New Drug Application (NDA): 202432
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NDA 202432 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Hospira, Intl Medication Sys, Nivagen Pharms Inc, Omnivium Pharms, Steriscience, and Abbott, and is included in twelve NDAs. It is available from thirteen 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
Summary for 202432
| Tradename: | SODIUM BICARBONATE |
| Applicant: | Hospira |
| Ingredient: | sodium bicarbonate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202432
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 202432
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202432 | ANDA | Hospira, Inc. | 0409-6625 | 0409-6625-14 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-14) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-22) |
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 202432 | ANDA | Hospira, Inc. | 0409-6625 | 0409-6625-35 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-6625-35) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-6625-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
| Approval Date: | Sep 26, 2017 | TE: | AP | RLD: | No | ||||
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