Details for New Drug Application (NDA): 211965
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NDA 211965 describes MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun Medical Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, and Mylan Labs Ltd, and is included in six NDAs. It is available from six suppliers. Additional details are available on the MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
The generic ingredient in MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER is magnesium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 211965
| Tradename: | MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | magnesium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211965
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 211965 | ANDA | Baxter Healthcare Corporation | 0338-1709 | 0338-1709-40 | 40 BAG in 1 CASE (0338-1709-40) / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/100ML | ||||
| Approval Date: | Aug 11, 2020 | TE: | AP | RLD: | No | ||||
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