isoproterenol hydrochloride · Bausch · NDA 006327, 006328, 010515, 011178
Isuprel
Earliest generic entry, as listed
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 · 010515-00110 Dec 2025
- 25 Oct 2026Generic approved · 010515-00118 May 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 006327 · 002 · discontinued | solution, inhalation | 0.5% | open |
| 006327 · 003 · discontinued | solution, inhalation | 1% | open |
| 006328 · 001 · discontinued | tablet, rectal, sublingual | 10MG | open |
| 006328 · 002 · discontinued | tablet, rectal, sublingual | 15MG | open |
| 010515 · 001 · RLD · discontinued | injectable, injection | 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011178 · 001 · discontinued | aerosol, metered, inhalation | 0.103MG/INH | open |