Suppliers and packages for tradename: FOMEPIZOLE
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FOMEPIZOLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368 | ANDA | American Regent, Inc. | 0517-0710-88 | 1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL | 2020-07-31 |
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368 | ANDA | American Regent, Inc. | 0517-0710-01 | 1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL | 2020-07-31 |
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368 | ANDA | American Regent, Inc. | 0517-0710-88 | 1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL | 2018-07-16 |
| Am Regent | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078368 | ANDA | American Regent, Inc. | 0517-0710-01 | 1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL | 2018-07-16 |
| Gland Pharma Ltd | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 216791 | ANDA | Sagent Pharmaceuticals | 25021-829-02 | 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL | 2023-11-15 |
| Gland Pharma Ltd | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 216791 | ANDA | Gland Pharma Limited | 68083-510-01 | 1 VIAL in 1 CARTON (68083-510-01) / 1.5 mL in 1 VIAL | 2023-07-06 |
| Mylan Institutional | FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078639 | ANDA | Mylan Institutional LLC | 67457-211-02 | 1 VIAL, GLASS in 1 CARTON (67457-211-02) / 1.5 mL in 1 VIAL, GLASS | 2012-10-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
