diltiazem hydrochloride · Bausch · NDA 018602, 020027, 020792
Cardizem
Earliest generic entry, as listed · earliest of 4 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
- 25 Oct 2026Generic approved · 018602-00114 Nov 2025
- 25 Oct 2026Generic approved · 018602-00125 Sep 2026
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018602 · 001 · RLD | tablet, oral | 30MG | open |
| 018602 · 002 · RLD | tablet, oral | 60MG | open |
| 018602 · 003 · RLD | tablet, oral | 90MG | open |
| 018602 · 004 · RLD | tablet, oral | 120MG | open |
| 020027 · 001 · RLD · discontinued | injectable, injection | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020027 · 003 · RLD · discontinued | injectable, injection | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020792 · 001 · discontinued | injectable, injection | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |