ANDA 74835, held by Aurobindo Pharma Ltd. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 74835 (Nortriptyline Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 30, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 1997 | 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 |
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
