ZIPRASIDONE MESYLATE | N020919 | VIATRIS SPECIALTY LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from RegCon Solutions, LLC FDA-2024-P-0425 · 8 docket documents RegCon Solutions, LLC submitted this suitability petition under Section 505(j) requesting FDA approval to file an abbreviated new drug application (ANDA) for Ziprasidone Mesylate Injection 20 mg/mL in a prefilled syringe, proposing a change in dosage form from the lyophilized reference listed drug G | Suitability | 2024-01-23 | Partially Denied | RegCon Solutions, LLC |
Citizen Petition From Gland Pharma, Inc. FDA-2015-P-0547 · 6 docket documents Gland Pharma Limited submitted this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Ziprasidone Mesylate for Injection in strengths of 10 mg base per 0.5 mL vial and 40 mg base per 2 mL vial suitable for submissi | Other | 2015-02-20 | Open | Gland Pharma, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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