Details for New Drug Application (NDA): 216042
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NDA 216042 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 216042
| Tradename: | SODIUM BICARBONATE |
| Applicant: | Long Grove Pharms |
| Ingredient: | sodium bicarbonate |
| Patents: | 0 |
Pharmacology for NDA: 216042
| Mechanism of Action | Alkalinizing Activity |
Suppliers and Packaging for NDA: 216042
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 216042 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-286 | 75834-286-20 | 20 VIAL in 1 CARTON (75834-286-20) / 50 mL in 1 VIAL (75834-286-01) |
| SODIUM BICARBONATE | sodium bicarbonate | INJECTABLE;INJECTION | 216042 | ANDA | Long Grove Pharmaceuticals, LLC | 81298-7620 | 81298-7620-3 | 20 VIAL in 1 CARTON (81298-7620-3) / 50 mL in 1 VIAL (81298-7620-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MEQ/ML | ||||
| Approval Date: | Feb 27, 2024 | TE: | AP | RLD: | No | ||||
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