Orange Book product
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Orange Book ANDA 090713 · TEVA PHARMACEUTICALS USA · Prescription
Key facts
| Proprietary name | PALONOSETRON HYDROCHLORIDE |
|---|---|
| Active ingredients | PALONOSETRON HYDROCHLORIDE |
| Strength | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | ANDA090713 |
| Applicant holder | TEVA PHARMACEUTICALS USA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 23, 2018 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.