Details for New Drug Application (NDA): 205517
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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.
Summary for 205517
Tradename: | LINEZOLID |
Applicant: | Alkem Labs Ltd |
Ingredient: | linezolid |
Patents: | 0 |
Suppliers and Packaging for NDA: 205517
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LINEZOLID | linezolid | TABLET;ORAL | 205517 | ANDA | Major Pharmaceuticals | 0904-6553 | 0904-6553-04 | 30 BLISTER PACK in 1 CARTON (0904-6553-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
LINEZOLID | linezolid | TABLET;ORAL | 205517 | ANDA | Ascend Laboratories, LLC | 67877-419 | 67877-419-01 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-419-01) |
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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