Details for New Drug Application (NDA): 205517
NDA 205517 describes LINEZOLID, which is a drug marketed by Hetero Labs, Hikma, Caplin, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Steriscience, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Macleods Pharms, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-six NDAs. It is available from twenty-three suppliers. Additional details are available on the LINEZOLID profile page.
The generic ingredient in LINEZOLID is linezolid. There is one drug master file entry for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the linezolid profile page.
The generic ingredient in LINEZOLID is linezolid. There is one drug master file entry for this compound. Twenty-six 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 | A-S Medication Solutions | 50090-8044 | 50090-8044-0 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-8044-0) |
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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