mesalamine · Mylan Speciality Lp · NDA 019618, 019919
Rowasa
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
- Generic approved · ANDA 220016, Klm Labs Pvt · 019618-001Approved 31 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019618 · 001 · RLD | enema, rectal | 4GM/60ML | open |
| 019919 · 001 · RLD · discontinued | suppository, rectal | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |