amlodipine besylate · Viatris · NDA 019787
Norvasc
Earliest generic entry, as listed · earliest of 3 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 210489, Ipca Labs Ltd · 019787-001Approved 22 Sep 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219686, Teva Pharms Inc · 019787-001Approved 22 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019787 · 001 · RLD | tablet, oral | EQ 2.5MG BASE | open |
| 019787 · 002 · RLD | tablet, oral | EQ 5MG BASE | open |
| 019787 · 003 · RLD | tablet, oral | EQ 10MG BASE | open |