Details for New Drug Application (NDA): 217594
✉ Email this page to a colleague
NDA 217594 describes SODIUM BICARBONATE, which is a drug marketed by Exela Pharma, Hospira, Intl Medication Sys, Long Grove Pharms, Omnivium Pharms, Steriscience, and Abbott, and is included in twelve NDAs. It is available from sixteen 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. Sixteen 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. Sixteen 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 | INJECTABLE;INJECTION | 217594 | ANDA | Sun Pharmaceutical Industries Limited | 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 | INJECTABLE;INJECTION | 217594 | ANDA | Steriscience Specialties Private Limited | 82449-000 | 82449-000-05 | 20 VIAL in 1 CARTON (82449-000-05) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
| Approval Date: | Jun 28, 2023 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
