Details for New Drug Application (NDA): 206485
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NDA 206485 describes MAGNESIUM SULFATE IN PLASTIC CONTAINER, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hq Spclt Pharma, Milla Pharms, and Mylan Labs Ltd, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the MAGNESIUM SULFATE IN PLASTIC CONTAINER profile page.
The generic ingredient in MAGNESIUM SULFATE 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 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 206485
| Tradename: | MAGNESIUM SULFATE IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | magnesium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 206485 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1373 | 51662-1373-1 | 50 mL in 1 BAG (51662-1373-1) |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 206485 | ANDA | Fresenius Kabi USA, LLC | 63323-106 | 63323-106-01 | 24 BAG in 1 CASE (63323-106-01) / 100 mL in 1 BAG (63323-106-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4GM/100ML (40MG/ML) | ||||
| Approval Date: | Mar 15, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4GM/50ML (80MG/ML) | ||||
| Approval Date: | Mar 15, 2016 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/50ML (40MG/ML) | ||||
| Approval Date: | Mar 15, 2016 | TE: | AP | RLD: | No | ||||
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