Risperidone

ANDA 76996, held by Actavis Labs Fl Inc. Risperidone.

As of Nov 13, 2026, ANDA 76996 (Risperidone), held by Actavis Labs Fl Inc, was first approved by FDA on Apr 19, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 19, 2011
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
Apr 19, 2011	Original application	Approved	None posted

Products

5 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
Risperidone3MG · tablet, orally disintegrating;oral	Risperidone	Discontinued
Risperidone4MG · tablet, orally disintegrating;oral	Risperidone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jul 1, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jan 22, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jan 14, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Dec 11, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Dec 11, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Apr 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 76996
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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