Risperidone

ANDA 77769, held by Heritage Pharma Avet. Risperidone.

As of Nov 13, 2026, ANDA 77769 (Risperidone), held by Heritage Pharma Avet, was first approved by FDA on Oct 16, 2008, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 16, 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
Oct 16, 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


Jul 3, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Oct 13, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Nov 2, 2015	Supplement 1Labeling	Approved	None posted
Nov 28, 2011	Supplement 2Labeling	Approved	None posted
Oct 16, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77769
Drugs@FDA: Overview at FDA
Company: Heritage Pharma Avet

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