Paroxetine Hydrochloride

ANDA 212645, held by Cadila Pharms Ltd. Paroxetine Hydrochloride.

As of Nov 15, 2026, ANDA 212645 (Paroxetine Hydrochloride), held by Cadila Pharms Ltd, was first approved by FDA on Aug 27, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 27, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Paroxetine extended-release tablets are indicated in adults for the treatment of:

Major depressive disorder (MDD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 27, 2021	Original application	Approved	None posted

Products

3 strengths and forms


Paroxetine HydrochlorideEQ 12.5MG BASE · tablet, extended release;oral	Paroxetine Hydrochloride	Rx
Paroxetine HydrochlorideEQ 25MG BASE · tablet, extended release;oral	Paroxetine Hydrochloride	Rx
Paroxetine HydrochlorideEQ 37.5MG BASE · tablet, extended release;oral	Paroxetine Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 29, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Aug 29, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Mar 23, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Aug 27, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 212645
Drugs@FDA: Overview at FDA
Company: Cadila Pharmaceuticals

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