Details for New Drug Application (NDA): 216364
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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. Thirteen suppliers are listed for this compound. Additional details are available on the sodium bicarbonate profile page.
Summary for 216364
Tradename: | SODIUM BICARBONATE |
Applicant: | Omnivium Pharms |
Ingredient: | sodium bicarbonate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216364
Mechanism of Action | Alkalinizing Activity |
Suppliers and Packaging for NDA: 216364
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 216364 | ANDA | NORTHSTAR RX LLC | 72603-209 | 72603-209-25 | 25 VIAL in 1 CARTON (72603-209-25) / 50 mL in 1 VIAL (72603-209-01) |
SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 216364 | ANDA | OMNIVIUM PHARMACEUTICALS LLC. | 81665-200 | 81665-200-05 | 20 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
Approval Date: | Jun 15, 2023 | TE: | AP | RLD: | No |
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