Details for New Drug Application (NDA): 218475
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NDA 218475 describes EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is epinephrine bitartrate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.
The generic ingredient in EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE is epinephrine bitartrate. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate profile page.
Summary for 218475
| Tradename: | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | epinephrine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 218475
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Suppliers and Packaging for NDA: 218475
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | epinephrine bitartrate | SOLUTION;INTRAVENOUS | 218475 | NDA | Baxter Healthcare Corporation | 0338-0024 | 0338-0024-20 | 20 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | ||||
| Approval Date: | Feb 28, 2025 | TE: | RLD: | Yes | |||||
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