Risperidone

ANDA 90347, held by Sun Pharma Canada. Risperidone.

As of Nov 13, 2026, ANDA 90347 (Risperidone), held by Sun Pharma Canada, was first approved by FDA on Feb 7, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 7, 2011
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 7, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Risperidone1MG/ML · solution;oral	Risperidone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Feb 13, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Feb 13, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Mar 1, 2012	Supplement 2Labeling	Approved	None posted
Nov 10, 2011	Supplement 1Labeling	Approved	None posted
Feb 7, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90347
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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