Details for New Drug Application (NDA): 204764
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NDA 204764 describes LINEZOLID, which is a drug marketed by Hetero Labs, Hikma, Eugia Pharma, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sandoz, Teva Pharms, Alembic, Alkem Labs Ltd, Amneal Pharms, Chartwell Rx, Gate Pharms, Glenmark Speclt, Hetero Labs Ltd V, Novel Labs Inc, Rising, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the LINEZOLID profile page.
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.
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 204764
| Tradename: | LINEZOLID |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | linezolid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204764
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 204764 | ANDA | Fresenius Kabi USA, LLC | 63323-713 | 63323-713-13 | 10 BAG in 1 CASE (63323-713-13) / 300 mL in 1 BAG (63323-713-03) |
| LINEZOLID | linezolid | SOLUTION;INTRAVENOUS | 204764 | ANDA | Hp Halden Pharma AS | 66298-7131 | 66298-7131-3 | 300 mL in 1 BAG (66298-7131-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 600MG/300ML (2MG/ML) | ||||
| Approval Date: | Mar 15, 2016 | TE: | AP | RLD: | No | ||||
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