Details for New Drug Application (NDA): 078639
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The generic ingredient in FOMEPIZOLE is fomepizole. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fomepizole profile page.
Summary for 078639
Tradename: | FOMEPIZOLE |
Applicant: | Mylan Institutional |
Ingredient: | fomepizole |
Patents: | 0 |
Suppliers and Packaging for NDA: 078639
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078639 | ANDA | Mylan Institutional LLC | 67457-211 | 67457-211-02 | 1 VIAL, GLASS in 1 CARTON (67457-211-02) / 1.5 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.5GM/1.5ML (1GM/ML) | ||||
Approval Date: | Mar 3, 2008 | TE: | AP | RLD: | No |
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