Details for New Drug Application (NDA): 209911
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NDA 209911 describes MAGNESIUM SULFATE IN PLASTIC CONTAINER, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland, Hospira, Hq Spclt Pharma, Milla Pharms, and Mylan Labs Ltd, and is included in eight NDAs. It is available from thirteen 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. Twenty 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. Twenty suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.
Summary for 209911
| Tradename: | MAGNESIUM SULFATE IN PLASTIC CONTAINER |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | magnesium sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINER | magnesium sulfate | INJECTABLE;INJECTION | 209911 | ANDA | Mylan Institutional LLC | 67457-553 | 67457-553-00 | 1 BAG in 1 POUCH (67457-553-00) / 50 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2GM/50ML (40MG/ML) | ||||
| Approval Date: | Sep 14, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 4GM/100ML (40MG/ML) | ||||
| Approval Date: | Sep 14, 2018 | TE: | RLD: | No | |||||
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