NDA 18276, held by Upjohn. Alprazolam.
As of Nov 13, 2026, NDA 18276 (Xanax), held by Upjohn, was first approved by FDA on Oct 16, 1981, with 39 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Anxiety Disorders Alprazolam Tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns.
| Nov 6, 1990 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Oct 16, 1981 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Xanax0.25MG · tablet;oral | Alprazolam | RxReference drug |
| Xanax0.5MG · tablet;oral | Alprazolam | RxReference drug |
| Xanax1MG · tablet;oral | Alprazolam | RxReference drug |
| Xanax2MG · tablet;oral | Alprazolam | RxReference drug |
| Jan 13, 2023 | Supplement 59Labeling · Standard review | Approved | |
| Mar 1, 2021 | Supplement 55Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 58Labeling | Approved | |
| Dec 16, 2016 | Supplement 52Labeling | Approved | |
| Aug 8, 2014 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 23, 2011 | Supplement 45Labeling | Approved | |
| Jun 1, 2011 | Supplement 44Labeling | Approved | |
| Apr 2, 2004 | Supplement 39Labeling · Standard review | Approved | |
| Apr 2, 2004 | Supplement 38Labeling · Standard review | Approved | |
| Nov 7, 2002 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| May 2, 2000 | Supplement 35Labeling · Standard review | Approved | |
| Nov 16, 1999 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1998 | Supplement 34Labeling · Standard review | Approved | None posted |
| Dec 20, 1996 | Supplement 33Labeling · Standard review | Approved | |
| Apr 18, 1996 | Supplement 32Labeling · Standard review | Approved | None posted |
| Jun 22, 1994 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1993 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1993 | Supplement 31Labeling · Standard review | Approved | None posted |
| May 21, 1993 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1992 | Supplement 28Labeling · Standard review | Approved | None posted |
| Nov 6, 1990 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Nov 6, 1990 | Supplement 15Labeling | Approved | None posted |
| Oct 23, 1990 | Supplement 16Labeling | Approved | None posted |
| Oct 22, 1990 | Supplement 21Labeling | Approved | None posted |
| Mar 24, 1989 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1988 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1988 | Supplement 20Labeling | Approved | None posted |
| Jul 26, 1988 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Mar 25, 1988 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1987 | Supplement 5Labeling | Approved | None posted |
| Feb 11, 1987 | Supplement 13Labeling | Approved | None posted |
| Jan 28, 1987 | Supplement 10Labeling | Approved | None posted |
| Jan 12, 1987 | Supplement 7Labeling | Approved | None posted |
| Jul 16, 1986 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1986 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1985 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1985 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 3Labeling | Approved | None posted |
| Nov 18, 1983 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1981 | Original applicationNew molecular entity · 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
