Paroxetine Hydrochloride

ANDA 75356, held by Apotex. Paroxetine Hydrochloride.

As of Nov 15, 2026, ANDA 75356 (Paroxetine Hydrochloride), held by Apotex, was first approved by FDA on Jul 30, 2003, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2003
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine tablets is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of: Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jul 30, 2003	Original application	Approved	Letter

Products

4 strengths and forms


Paroxetine HydrochlorideEQ 10MG BASE · tablet;oral	Paroxetine Hydrochloride	Rx
Paroxetine HydrochlorideEQ 20MG BASE · tablet;oral	Paroxetine Hydrochloride	Rx
Paroxetine HydrochlorideEQ 30MG BASE · tablet;oral	Paroxetine Hydrochloride	Rx
Paroxetine HydrochlorideEQ 40MG BASE · tablet;oral	Paroxetine Hydrochloride	Rx

All 18 submissions, including labeling and manufacturing supplements


Jul 21, 2020	Supplement 37Labeling · Standard review	Approved	None posted
Dec 21, 2014	Supplement 36Labeling · Standard review	Approved	None posted
Dec 31, 2013	Supplement 35Labeling · Standard review	Approved	None posted
Jan 5, 2012	Supplement 33Labeling	Approved	None posted
Dec 15, 2011	Supplement 34Labeling	Approved	None posted
Jul 27, 2011	Supplement 32Labeling	Approved	None posted
Mar 25, 2010	Supplement 31Labeling	Approved	None posted
Oct 26, 2009	Supplement 30Labeling	Approved	None posted
May 14, 2009	Supplement 29Labeling	Approved	None posted
Feb 5, 2008	Supplement 25Labeling	Approved	None posted
Feb 5, 2008	Supplement 24Labeling	Approved	None posted
Feb 5, 2007	Supplement 23Labeling	Approved	None posted
Feb 5, 2007	Supplement 21Labeling	Approved	None posted
Jun 29, 2006	Supplement 19Labeling	Approved	None posted
Jun 29, 2006	Supplement 18Labeling	Approved	None posted
Dec 27, 2005	Supplement 16Labeling	Approved	None posted
Dec 2, 2005	Supplement 15Labeling	Approved	None posted
Jul 30, 2003	Original application	Approved	Letter

Identifiers

Application: ANDA 75356
Drugs@FDA: Overview at FDA
Company: Apotex

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