Details for New Drug Application (NDA): 216791
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NDA 216791 describes FOMEPIZOLE, which is a drug marketed by Am Regent, Gland Pharma Ltd, Mylan Institutional, and Navinta Llc, and is included in five NDAs. It is available from six suppliers. Additional details are available on the FOMEPIZOLE profile page.
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.
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 216791
| Tradename: | FOMEPIZOLE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | fomepizole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216791
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 216791 | ANDA | Sagent Pharmaceuticals | 25021-829 | 25021-829-02 | 1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL |
| FOMEPIZOLE | fomepizole | INJECTABLE;INJECTION | 216791 | ANDA | Gland Pharma Limited | 68083-510 | 68083-510-01 | 1 VIAL in 1 CARTON (68083-510-01) / 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: | Jul 6, 2023 | TE: | AP | RLD: | No | ||||
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