Relieves symptoms of depression. ANDA 213441, held by Zydus Lifesciences. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 213441 (Nortriptyline Hydrochloride), held by Zydus Lifesciences, was first approved by FDA on Feb 24, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2021 | 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
