Risperidone

ANDA 78516, held by Zydus Pharms USA. Risperidone.

As of Nov 13, 2026, ANDA 78516 (Risperidone), held by Zydus Pharms USA, was first approved by FDA on May 1, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: May 1, 2009
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
May 1, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Risperidone0.5MG · tablet, orally disintegrating;oral	Risperidone	Rx
Risperidone2MG · tablet, orally disintegrating;oral	Risperidone	Rx

All 13 submissions, including labeling and manufacturing supplements


Nov 26, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Nov 26, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 26, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Nov 26, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 2, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Apr 16, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Jul 25, 2012	Supplement 5Labeling	Approved	None posted
Apr 30, 2012	Supplement 6Labeling	Approved	None posted
Jul 11, 2011	Supplement 4Labeling	Approved	None posted
Jun 10, 2011	Supplement 3Labeling	Approved	None posted
Dec 29, 2010	Supplement 2Labeling	Approved	None posted
Nov 6, 2009	Supplement 1Manufacturing	Approved	None posted
May 1, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78516
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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