Details for New Drug Application (NDA): 078845
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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: 078845
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | TABLET;ORAL | 078845 | ANDA | Rising Pharma Holdings, Inc. | 64980-561 | 64980-561-02 | 20 TABLET in 1 BOTTLE (64980-561-02) |
LINEZOLID | linezolid | TABLET;ORAL | 078845 | ANDA | Rising Pharma Holdings, Inc. | 64980-561 | 64980-561-03 | 30 TABLET in 1 BOTTLE (64980-561-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Dec 21, 2015 | TE: | AB | RLD: | No |
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