Details for New Drug Application (NDA): 021130
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The generic ingredient in ZYVOX 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: 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 | Pharmacia & Upjohn Company LLC | 0009-5138 | 0009-5138-03 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (0009-5138-03) / 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DISCN | Dosage: | TABLET;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Apr 18, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021130
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-002 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-001 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-001 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | ZYVOX | linezolid | TABLET;ORAL | 021130-002 | Apr 18, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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