Details for New Drug Application (NDA): 219777
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NDA 219777 describes MAGNESIUM SULFATE, which is a drug marketed by B Braun Medical, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Baxter Hlthcare Corp, Hq Spclt Pharma, Pharmobedient, Amneal, Gland, Milla Pharms, and Mylan Labs Ltd, and is included in twenty NDAs. It is available from ten 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. Twenty 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. Twenty suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 219777
| Tradename: | MAGNESIUM SULFATE |
| Applicant: | Aspiro |
| Ingredient: | magnesium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219777
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE | magnesium sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 219777 | ANDA | Camber Pharmaceuticals, Inc. | 31722-394 | 31722-394-32 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-32) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-394-31) |
| MAGNESIUM SULFATE | magnesium sulfate | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 219777 | ANDA | Camber Pharmaceuticals, Inc. | 31722-394 | 31722-394-33 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-394-33) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-394-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | 1GM/2ML (500MG/ML) | ||||
| Approval Date: | May 28, 2025 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | 5GM/10ML (500MG/ML) | ||||
| Approval Date: | May 28, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Strength | 10GM/20ML (500MG/ML) | ||||
| Approval Date: | May 28, 2025 | TE: | AP | RLD: | No | ||||
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