Orange Book product
NALBUPHINE 10MG/ML (10MG/ML)
Orange Book ANDA 070751 · ABRAXIS PHARMACEUTICAL PRODUCTS · Discontinued
Key facts
| Proprietary name | NALBUPHINE |
|---|---|
| Active ingredients | NALBUPHINE HYDROCHLORIDE |
| Strength | 10MG/ML (10MG/ML) |
| Dosage form | SOLUTION |
| Route | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Application | ANDA070751 |
| Applicant holder | ABRAXIS PHARMACEUTICAL PRODUCTS |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jul 2, 1986 |
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.