Details for New Drug Application (NDA): 020696
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NDA 020696 describes ANTIZOL, which is a drug marketed by Par Pharm Inc and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ANTIZOL profile page.
The generic ingredient in ANTIZOL is fomepizole. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fomepizole profile page.
The generic ingredient in ANTIZOL is fomepizole. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fomepizole profile page.
Summary for 020696
| Tradename: | ANTIZOL |
| Applicant: | Par Pharm Inc |
| Ingredient: | fomepizole |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 4, 1997 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 30, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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