Details for New Drug Application (NDA): 215370
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NDA 215370 describes MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 profile page.
The generic ingredient in MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.
The generic ingredient in MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.
Summary for 215370
| Tradename: | MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate | INJECTABLE;INJECTION | 215370 | ANDA | Fresenius Kabi USA, LLC | 65219-387 | 65219-387-05 | 20 BAG in 1 CASE (65219-387-05) / 500 mL in 1 BAG (65219-387-00) |
| MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5 | magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate | INJECTABLE;INJECTION | 215370 | ANDA | Fresenius Kabi USA, LLC | 65219-387 | 65219-387-10 | 10 BAG in 1 CASE (65219-387-10) / 1000 mL in 1 BAG (65219-387-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100ML | ||||
| Approval Date: | Jun 29, 2022 | TE: | RLD: | No | |||||
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