loperamide hydrochloride · Kenvue Brands · NDA 019487, 019860
Imodium A-D
Earliest generic entry, as listed · earliest of 2 marketed strengths
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 220153, Pharmazone · 019860-001Approved 17 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019487 · 001 · RLD · discontinued | solution, oral | 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019487 · 002 · RLD | solution, oral | 1MG/7.5ML | open |
| 019860 · 001 · RLD | tablet, oral | 2MG | open |