NDA 20200, held by Abbvie. Nalbuphine Hydrochloride.
As of Nov 13, 2026, NDA 20200 (Nalbuphine Hydrochloride), held by Abbvie, was first approved by FDA on Mar 12, 1993, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 1993 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nalbuphine Hydrochloride1.5MG/ML · injectable;injection | Nalbuphine Hydrochloride | Discontinued |
| Nov 12, 2002 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 31, 1996 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 12, 1993 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
