Risperidone

ANDA 76908, held by Chartwell Rx. Risperidone.

As of Nov 13, 2026, ANDA 76908 (Risperidone), held by Chartwell Rx, was first approved by FDA on Mar 12, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2012
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
Mar 12, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Risperidone0.5MG · tablet, orally disintegrating;oral	Risperidone	Discontinued
Risperidone1MG · tablet, orally disintegrating;oral	Risperidone	Discontinued
Risperidone2MG · tablet, orally disintegrating;oral	Risperidone	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jun 12, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Mar 12, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 76908
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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