Orange Book product
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML)
Orange Book NDA 022276 · HIKMA INTERNATIONAL PHARMACEUTICALS LLC · Prescription
Key facts
| Proprietary name | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
|---|---|
| Active ingredients | NICARDIPINE HYDROCHLORIDE |
| Strength | 40MG/200ML (0.2MG/ML) |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | NDA022276 |
| Applicant holder | HIKMA INTERNATIONAL PHARMACEUTICALS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Apr 7, 2016 |
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.