nicardipine hydrochloride · Hikma Intl Pharms · NDA 022276, 078405
Nicardipine Hydrochloride
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 219608, Qilu Pharm Hainan · 022276-001Approved 28 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022276 · 001 · RLD | injectable, injection | 25MG/10ML (2.5MG/ML) | open |
| 078405 · 001 · discontinued | injectable, injection | 25MG/10ML (2.5MG/ML) | open |