HALOPERIDOL | A070278 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma, LLC FDA-2026-P-4060 Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the FDC 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 (Haloperidol) tablets approved under NDA #015921 in 0.5 | Suitability | 2026-04-14 | Open | Appco Pharma, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1779
per ea
Lowest NADAC/Unit
$0.0914
per ea
Brand NDCs
0
Generic NDCs
8
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00378021410HALOPERIDOL 2 MG TABLET | $0.1779 | EA | Generic | — | 2026-10-21 |
| 51079073620HALOPERIDOL 5 MG TABLET | $0.1711 | EA | Generic | — | 2026-10-21 |
| 00378032710HALOPERIDOL 5 MG TABLET | $0.1711 | EA | Generic | — | 2026-10-21 |
| 00378025710HALOPERIDOL 1 MG TABLET | $0.1354 | EA | Generic | — | 2026-10-21 |
| 51079073420HALOPERIDOL 1 MG TABLET | $0.1354 | EA | Generic | — | 2026-10-21 |
| 51079073320HALOPERIDOL 0.5 MG TABLET | $0.0914 | EA | Generic | — | 2026-10-21 |
| 00378035101HALOPERIDOL 0.5 MG TABLET | $0.0914 | EA | Generic | — | 2026-10-21 |
| 00378035110HALOPERIDOL 0.5 MG TABLET | $0.0914 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.