Details for New Drug Application (NDA): 078537
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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 078537
Tradename: | FOMEPIZOLE |
Applicant: | Navinta Llc |
Ingredient: | fomepizole |
Patents: | 0 |
Suppliers and Packaging for NDA: 078537
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078537 | ANDA | Navinta LLC | 68475-510 | 68475-510-01 | 1 VIAL in 1 CARTON (68475-510-01) / 1.5 mL in 1 VIAL |
FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 078537 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1478 | 70710-1478-1 | 1 VIAL in 1 CARTON (70710-1478-1) / 1.5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1.5GM/1.5ML (1GM/ML) | ||||
Approval Date: | Mar 6, 2008 | TE: | AP | RLD: | No |
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