Orange Book product
PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Orange Book ANDA 201533 · DR REDDYS LABORATORIES LTD · Discontinued
Key facts
| Proprietary name | PALONOSETRON HYDROCHLORIDE |
|---|---|
| Active ingredients | PALONOSETRON HYDROCHLORIDE |
| Strength | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | ANDA201533 |
| Applicant holder | DR REDDYS LABORATORIES LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 21, 2016 |
At a glance
- 1–9 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.