Orange Book product
CARDENE 25MG/10ML (2.5MG/ML) **Federal Register determination that…
Orange Book NDA 019734 · CHIESI USA INC · Prescription
Key facts
| Proprietary name | CARDENE |
|---|---|
| Active ingredients | NICARDIPINE HYDROCHLORIDE |
| Strength | 25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | NDA019734 |
| Applicant holder | CHIESI USA INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 30, 1992 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.