haloperidol · Ortho Mcneil · NDA 015921, 015922, 015923, 018701
Haldol
Earliest generic entry, as listed · earliest of 10 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 214470, Alembic · 015921-001Approved 4 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218210, Ajanta Pharma Ltd · 015921-001Approved 14 Sep 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218162, Creekwood Pharms · 015921-001Approved 18 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 015921 · 001 · RLD · discontinued | tablet, oral | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015921 · 002 · RLD · discontinued | tablet, oral | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015921 · 003 · RLD · discontinued | tablet, oral | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015921 · 004 · RLD · discontinued | tablet, oral | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015921 · 005 · RLD · discontinued | tablet, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015921 · 006 · RLD · discontinued | tablet, oral | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015922 · 001 · RLD · discontinued | concentrate, oral | EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 015923 · 001 · RLD · discontinued | injectable, injection | EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018701 · 001 · RLD · discontinued | injectable, injection | EQ 50MG BASE/ML | open |
| 018701 · 002 · RLD · discontinued | injectable, injection | EQ 100MG BASE/ML | open |