albuterol sulfate · Glaxosmithkline · NDA 018473, 019112, 019269, 019621, 019773
Ventolin
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018473 · 001 · discontinued | aerosol, metered, inhalation | 0.09MG/INH | open |
| 019112 · 001 · discontinued | tablet, oral | EQ 2MG BASE | open |
| 019112 · 002 · discontinued | tablet, oral | EQ 4MG BASE | open |
| 019269 · 002 · discontinued | solution, inhalation | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019621 · 001 · discontinued | syrup, oral | EQ 2MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019773 · 001 · RLD · discontinued | solution, inhalation | EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |