Details for New Drug Application (NDA): 211091
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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. Fourteen 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 |
Formulation / Manufacturing: | see details |
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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