labetalol hydrochloride · Schering · NDA 018686, 018687
Normodyne
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
- Generic approved · ANDA 217949, Macleods Pharms Ltd · 018687-001Approved 23 Sep 2025Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018686 · 001 · RLD · discontinued | injectable, injection | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018687 · 001 · RLD · discontinued | tablet, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018687 · 002 · RLD · discontinued | tablet, oral | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018687 · 003 · RLD · discontinued | tablet, oral | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 018687 · 004 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |