Orange Book product
NALBUPHINE HYDROCHLORIDE 200MG/10ML (20MG/ML)
Orange Book ANDA 216049 · SOMERSET THERAPEUTICS LLC · Prescription
Key facts
| Proprietary name | NALBUPHINE HYDROCHLORIDE |
|---|---|
| Active ingredients | NALBUPHINE HYDROCHLORIDE |
| Strength | 200MG/10ML (20MG/ML) |
| Dosage form | SOLUTION |
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Application | ANDA216049 |
| Applicant holder | SOMERSET THERAPEUTICS LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 19, 2024 |
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.