HALOPERIDOL | A070278 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma, LLC FDA-2026-P-4060 Appco Pharma, LLC filed a Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Haloperidol Tablets USP in 0.25 mg and 2.5 mg strengths, which differ from the Reference Listed Drug HALDOL (approved in 0.5 mg, 1 | Suitability | 2026-04-14 | Open | Appco Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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