Risperidone

ANDA 77860, held by Watson Labs. Risperidone.

As of Nov 14, 2026, ANDA 77860 (Risperidone), held by Watson Labs, was first approved by FDA on Dec 5, 2008, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2008
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 5, 2008	Original application	Approved	None posted

Products

6 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Aug 27, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Feb 13, 2012	Supplement 2Labeling	Approved	None posted
Apr 22, 2011	Supplement 1Labeling	Approved	None posted
Dec 5, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77860
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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