Details for New Drug Application (NDA): 021130
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NDA 021130 describes ZYVOX, which is a drug marketed by Pfizer and is included in three NDAs. It is available from three suppliers. Additional details are available on the ZYVOX profile page.
The generic ingredient in ZYVOX 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.
The generic ingredient in ZYVOX 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: 021130
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYVOX | linezolid | TABLET;ORAL | 021130 | NDA | Pharmacia & Upjohn Company LLC | 0009-5138 | 0009-5138-02 | 20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02) |
| ZYVOX | linezolid | TABLET;ORAL | 021130 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-1307 | 59762-1307-2 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Apr 18, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Apr 18, 2000 | TE: | RLD: | Yes | |||||
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