Orange Book product
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML
Orange Book ANDA 091483 · AMNEAL PHARMACEUTICALS · Prescription
Key facts
| Proprietary name | ONDANSETRON HYDROCHLORIDE |
|---|---|
| Active ingredients | ONDANSETRON HYDROCHLORIDE |
| Strength | EQ 4MG BASE/5ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA091483 |
| Applicant holder | AMNEAL PHARMACEUTICALS |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 31, 2011 |
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.