Details for New Drug Application (NDA): 211091
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NDA 211091 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 211091
| Tradename: | SODIUM BICARBONATE |
| Applicant: | Exela Pharma |
| Ingredient: | sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 211091
| Mechanism of Action | Alkalinizing Activity |
Suppliers and Packaging for NDA: 211091
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 211091 | ANDA | A-S Medication Solutions | 50090-6813 | 50090-6813-0 | 1 VIAL in 1 CARTON (50090-6813-0) / 50 mL in 1 VIAL |
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 211091 | ANDA | Exela Pharma Sciences, LLC | 51754-5001 | 51754-5001-4 | 25 VIAL in 1 CARTON (51754-5001-4) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MEQ/ML | ||||
| Approval Date: | Jun 20, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.9MEQ/ML | ||||
| Approval Date: | Jun 20, 2019 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
| Approval Date: | Jun 20, 2019 | TE: | AP | RLD: | No | ||||
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