FDA Orange Book · active-ingredient family
Nalbuphine hydrochloride
Nalbuphine hydrochloride is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NUBAIN · NDA 018024
2
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NUBAINRLD×5 | PH HEALTH | NDA 018024 | — | Approved Prior to Jan 1, 1982 | |
| NALBUPHINE HYDROCHLORIDE | ABBVIE | NDA 020200 | — | Mar 12, 1993 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALBUPHINE HYDROCHLORIDE×2 | SOMERSET THERAPS LLC | ANDA 216050 | AP | Sep 19, 2024 | |
| NALBUPHINE HYDROCHLORIDE×2 | SOMERSET THERAPS LLC | ANDA 216049 | AP | Sep 19, 2024 | |
| NALBUPHINE HYDROCHLORIDE×2 | RISING | ANDA 206506 | — | Feb 06, 2019 | |
| NALBUPHINE HYDROCHLORIDE×2 | RISING | ANDA 207595 | — | Jan 11, 2019 | |
| NALBUPHINE HYDROCHLORIDE×2 | DR REDDYS | ANDA 074471 | — | Mar 19, 1998 | |
| NALBUPHINE HYDROCHLORIDE×2 | IGI LABS INC | ANDA 072070 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE | IGI LABS INC | ANDA 072071 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE | IGI LABS INC | ANDA 072072 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE×2 | IGI LABS INC | ANDA 072073 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE | IGI LABS INC | ANDA 072074 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE | IGI LABS INC | ANDA 072075 | — | Apr 10, 1989 | |
| NALBUPHINE HYDROCHLORIDE | ABBOTT | ANDA 070917 | — | Feb 03, 1989 | |
| NALBUPHINE HYDROCHLORIDE | HOSPIRA | ANDA 070914 | AP | Feb 03, 1989 | |
| NALBUPHINE HYDROCHLORIDE | HOSPIRA | ANDA 070916 | AP | Feb 03, 1989 | |
| NALBUPHINE HYDROCHLORIDE | HOSPIRA | ANDA 070915 | AP | Feb 03, 1989 | |
| NALBUPHINE HYDROCHLORIDE | HOSPIRA | ANDA 070918 | AP | Feb 03, 1989 | |
| NALBUPHINE×2 | ABRAXIS PHARM | ANDA 070752 | — | Sep 24, 1986 | |
| NALBUPHINE×2 | ABRAXIS PHARM | ANDA 070751 | — | Jul 02, 1986 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Nalbuphine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
