Risperidone

As of Nov 13, 2026, ANDA 76904 (Risperidone), held by Hikma, was first approved by FDA on Jul 29, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 29, 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
Jul 29, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Sep 22, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Sep 22, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Sep 22, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Sep 22, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Sep 22, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Sep 22, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Sep 9, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Sep 9, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Sep 7, 2011	Supplement 4Labeling	Approved	None posted
Apr 25, 2011	Supplement 3Labeling	Approved	None posted
Jan 11, 2011	Supplement 2Labeling	Approved	None posted
Jul 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76904
Drugs@FDA: Overview at FDA
Company: Hikma

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