Details for New Drug Application (NDA): 200904
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The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Suppliers and Packaging for NDA: 200904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 200904 | ANDA | Sandoz Inc | 0781-3433 | 0781-3433-95 | 10 BAG in 1 CARTON (0781-3433-95) / 300 mL in 1 BAG (0781-3433-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/100ML (2MG/ML) | ||||
Approval Date: | Jul 16, 2015 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 600MG/300ML (2MG/ML) | ||||
Approval Date: | Jul 16, 2015 | TE: | AP | RLD: | No |
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