Risperidone

ANDA 78740, held by West Ward Pharms. Risperidone.

As of Nov 13, 2026, ANDA 78740 (Risperidone), held by West Ward Pharms, was first approved by FDA on May 29, 2009, with 8 approved supplements and 0 published complete response letters.

First approved: May 29, 2009
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 29, 2009	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 9 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Sep 12, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Oct 21, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Dec 31, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Dec 8, 2011	Supplement 4Labeling	Approved	None posted
Mar 15, 2011	Supplement 3Labeling	Approved	None posted
Feb 4, 2010	Supplement 1Labeling	Approved	None posted
May 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78740
Drugs@FDA: Overview at FDA
Company: West-Ward Pharmaceuticals

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