Details for New Drug Application (NDA): 206039
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NDA 206039 describes MAGNESIUM SULFATE, which is a drug marketed by B Braun Medical Inc, Exela Pharma, Fresenius Kabi Usa, Hospira, Baxter Hlthcare Corp, Hq Spclt Pharma, Mylan Labs Ltd, Amneal, Gland Pharma Ltd, and Milla Pharms, and is included in nineteen NDAs. It is available from eight suppliers. Additional details are available on the MAGNESIUM SULFATE profile page.
The generic ingredient in MAGNESIUM SULFATE 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 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 206039
| Tradename: | MAGNESIUM SULFATE |
| Applicant: | Exela Pharma |
| Ingredient: | magnesium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE | magnesium sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 206039 | ANDA | Exela Pharma Sciences, LLC | 51754-1000 | 51754-1000-4 | 25 VIAL, SINGLE-DOSE in 1 TRAY (51754-1000-4) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | 5GM/10ML (500MG/ML) | ||||
| Approval Date: | Dec 18, 2014 | TE: | RLD: | No | |||||
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