ANDA 74234, held by Rising. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 74234 (Nortriptyline Hydrochloride), held by Rising, was first approved by FDA on Jul 26, 1993, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 1993 | Original application | Approved | None posted |
| Nortriptyline HydrochlorideEQ 10MG BASE · capsule;oral | Nortriptyline Hydrochloride | Discontinued |
| Nortriptyline HydrochlorideEQ 25MG BASE · capsule;oral | Nortriptyline Hydrochloride | Discontinued |
| Nortriptyline HydrochlorideEQ 50MG BASE · capsule;oral | Nortriptyline Hydrochloride | Discontinued |
| Nortriptyline HydrochlorideEQ 75MG BASE · capsule;oral | Nortriptyline Hydrochloride | Discontinued |
| Oct 19, 2007 | Supplement 14Labeling | Approved | None posted |
| Jul 2, 2007 | Supplement 13Labeling | Approved | None posted |
| Apr 5, 2006 | Supplement 12Labeling | Approved | None posted |
| Jul 24, 2002 | Supplement 9Manufacturing | Approved | None posted |
| May 23, 2002 | Supplement 10Labeling | Approved | None posted |
| Mar 12, 1999 | Supplement 7Manufacturing | Approved | None posted |
| Mar 12, 1999 | Supplement 8Manufacturing | Approved | None posted |
| Apr 20, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Apr 20, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Apr 20, 1998 | Supplement 6Labeling | Approved | None posted |
| Feb 5, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Feb 18, 1997 | Supplement 2Labeling | Approved | None posted |
| Jun 28, 1995 | Supplement 1Labeling | Approved | None posted |
| Jul 26, 1993 | Original application | 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
