Risperidone

ANDA 78528, held by Sandoz. Risperidone.

As of Nov 13, 2026, ANDA 78528 (Risperidone), held by Sandoz, was first approved by FDA on Oct 16, 2009, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2009
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 16, 2009	Original application	Approved	None posted

Products

6 strengths and forms


Risperidone0.25MG · tablet;oral	Risperidone	Rx
Risperidone0.5MG · tablet;oral	Risperidone	Rx
Risperidone1MG · tablet;oral	Risperidone	Rx
Risperidone2MG · tablet;oral	Risperidone	Rx
Risperidone3MG · tablet;oral	Risperidone	Rx
Risperidone4MG · tablet;oral	Risperidone	Rx

All 10 submissions, including labeling and manufacturing supplements


Oct 21, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 18, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Nov 7, 2013	Supplement 4Labeling	Approved	None posted
Nov 28, 2011	Supplement 3Labeling	Approved	None posted
Aug 30, 2011	Supplement 2Labeling	Approved	None posted
Mar 16, 2011	Supplement 1Labeling	Approved	None posted
Oct 16, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78528
Drugs@FDA: Overview at FDA
Company: Sandoz

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