Risperidone

ANDA 79158, held by Lannett Co Inc. Risperidone.

As of Nov 13, 2026, ANDA 79158 (Risperidone), held by Lannett Co Inc, was first approved by FDA on Dec 3, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 3, 2010
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 3, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements


Nov 12, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Oct 22, 2012	Supplement 9Labeling · Standard review	Approved	None posted
Jan 30, 2012	Supplement 5Labeling	Approved	None posted
Nov 4, 2011	Supplement 3Labeling	Approved	None posted
Oct 26, 2011	Supplement 2Labeling	Approved	None posted
Apr 20, 2011	Supplement 1Labeling	Approved	None posted
Dec 3, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79158
Drugs@FDA: Overview at FDA
Company: Lannett Company

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