Paroxetine Hydrochloride

ANDA 78902, held by Mylan. Paroxetine Hydrochloride.

As of Nov 15, 2026, ANDA 78902 (Paroxetine Hydrochloride), held by Mylan, was first approved by FDA on Mar 13, 2008, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2008
Supplements approved: 11
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)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Mar 13, 2008	Original application	Approved	None posted

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 12 submissions, including labeling and manufacturing supplements


Jan 23, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Jan 23, 2023	Supplement 21Labeling · Standard review	Approved	None posted
Apr 16, 2020	Supplement 18Labeling · Standard review	Approved	None posted
Apr 16, 2020	Supplement 17Labeling · Standard review	Approved	None posted
Jul 2, 2015	Supplement 15Labeling · Standard review	Approved	None posted
Dec 31, 2013	Supplement 14Labeling · Standard review	Approved	None posted
Dec 27, 2011	Supplement 11Labeling	Approved	None posted
Jul 27, 2011	Supplement 10Labeling	Approved	None posted
May 12, 2011	Supplement 8Labeling	Approved	None posted
Mar 25, 2010	Supplement 7Labeling	Approved	None posted
Oct 15, 2009	Supplement 5Labeling	Approved	None posted
Mar 13, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78902
Drugs@FDA: Overview at FDA
Company: Mylan

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