chlorpromazine hydrochloride · Glaxosmithkline · NDA 009149, 011120
Thorazine
Earliest generic entry, as listed · earliest of 6 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 216678, Rubicon Research · 009149-032Approved 10 Oct 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216092, Msn · 009149-011Approved 26 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 16
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 009149 · 002 · discontinued | tablet, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 007 · discontinued | tablet, oral | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 011 · RLD · discontinued | injectable, injection | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 013 · discontinued | tablet, oral | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 018 · discontinued | tablet, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 020 · discontinued | tablet, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 022 · RLD · discontinued | syrup, oral | 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 024 · RLD · discontinued | suppository, rectal | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 032 · RLD · discontinued | concentrate, oral | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 033 · RLD · discontinued | suppository, rectal | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009149 · 043 · RLD · discontinued | concentrate, oral | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011120 · 016 · discontinued | capsule, extended release, oral | 30MG | open |
| 011120 · 017 · discontinued | capsule, extended release, oral | 75MG | open |
| 011120 · 018 · discontinued | capsule, extended release, oral | 150MG | open |
| 011120 · 019 · discontinued | capsule, extended release, oral | 200MG | open |
| 011120 · 020 · discontinued | capsule, extended release, oral | 300MG | open |