Details for New Drug Application (NDA): 200068
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The generic ingredient in LINEZOLID is linezolid. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.
Suppliers and Packaging for NDA: 200068
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | FOR SUSPENSION;ORAL | 200068 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0319 | 0054-0319-50 | 150 mL in 1 BOTTLE (0054-0319-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Jun 3, 2015 | TE: | AB | RLD: | No |
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