Details for New Drug Application (NDA): 217594
NDA 217594 describes SODIUM BICARBONATE, which is a drug marketed by Adaptis, Amneal, Aspiro, Baxter Hlthcare Corp, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Milla Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the SODIUM BICARBONATE profile page.
The generic ingredient in SODIUM BICARBONATE is sodium bicarbonate. There is one drug master file entry for this compound. Twenty-three 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 is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
Summary for 217594
| Tradename: | SODIUM BICARBONATE |
| Applicant: | Steriscience |
| Ingredient: | sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 217594
| Mechanism of Action | Alkalinizing Activity |
Suppliers and Packaging for NDA: 217594
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 217594 | ANDA | Sun Pharmaceutical Industries, Inc. | 70095-050 | 70095-050-03 | 25 VIAL in 1 CARTON (70095-050-03) / 50 mL in 1 VIAL (70095-050-01) |
| SODIUM BICARBONATE | sodium bicarbonate | SOLUTION;INTRAVENOUS | 217594 | ANDA | Medical Purchasing Solutions, LLC | 71872-7371 | 71872-7371-1 | 1 VIAL in 1 BAG (71872-7371-1) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MEQ/50ML (1MEQ/ML) | ||||
| Approval Date: | Jun 28, 2023 | TE: | AP | RLD: | No | ||||
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