nystatin · Chartwell Molecules · NDA 050299, 050576
Nilstat
Earliest generic entry, as listed
Open now
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 · 050299-0015 Feb 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050299 · 001 · RLD | suspension, oral | 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 050576 · 001 · RLD · discontinued | powder, oral | 100% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |