FOMEPIZOLE | N020696 | PAR PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gland Pharma Limited FDA-2021-P-0923 Gland Pharma Limited filed this citizen petition pursuant to 21 CFR 10.30 and 314.161 requesting the FDA to determine whether ANTIZOL (Fomepizole) Injection, 1.5 g/1.5 mL (NDA 020696), held by PAR Pharmaceutical Inc., was voluntarily withdrawn from sale for reasons of safety or effectiveness. The pe | Other | 2021-08-20 | Denied | Gland Pharma Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7553863 | Jun 30, 2027 | — | Yes | Yes | — | — |