labetalol hydrochloride · Alvogen · NDA 018716, 019425
Trandate
Earliest generic entry, as listed · earliest of 5 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
- 25 Oct 2026Generic approved · 019425-0012 Oct 2025
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018716 · 001 · RLD · discontinued | tablet, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018716 · 002 · RLD · discontinued | tablet, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018716 · 003 · RLD · discontinued | tablet, oral | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018716 · 004 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019425 · 001 · RLD · discontinued | injectable, injection | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |