NDA 18024, held by Ph Health. Nalbuphine Hydrochloride.
As of Nov 13, 2026, NDA 18024 (Nubain), held by Ph Health, was first approved by FDA on May 15, 1979, with 37 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 1986 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| May 15, 1979 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nubain10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular, intravenous, subcutaneous | Nalbuphine Hydrochloride | DiscontinuedReference drug |
| Nubain20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular, intravenous, subcutaneous | Nalbuphine Hydrochloride | DiscontinuedReference drug |
| Nubain100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular, intravenous, subcutaneous | Nalbuphine Hydrochloride | DiscontinuedReference drug |
| Nubain20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular, intravenous, subcutaneous | Nalbuphine Hydrochloride | DiscontinuedReference drug |
| Nubain200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intramuscular, intravenous, subcutaneous | Nalbuphine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Supplement 44Labeling · Standard review | Approved | |
| Dec 15, 2023 | Supplement 43Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 42Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 41Labeling · Standard review | Approved | |
| Aug 23, 2005 | Supplement 40Labeling · Standard review | Approved | |
| Apr 30, 2003 | Supplement 36Labeling · Standard review | Approved | |
| Oct 25, 2002 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Apr 16, 2002 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2002 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Dec 15, 1995 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1994 | Supplement 32Labeling | Approved | None posted |
| Oct 15, 1993 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1990 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1988 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 10, 1988 | Supplement 27Labeling | Approved | None posted |
| Mar 3, 1988 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1987 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1987 | Supplement 26Labeling | Approved | None posted |
| Oct 23, 1986 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Nov 28, 1984 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1984 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 13, 1984 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1983 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1983 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1983 | Supplement 17Labeling | Approved | None posted |
| May 27, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 27, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 20, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 20, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1979 | Supplement 1Labeling | Approved | None posted |
| May 15, 1979 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
