Risperidone

ANDA 78744, held by Wockhardt Bio AG. Risperidone.

As of Nov 13, 2026, ANDA 78744 (Risperidone), held by Wockhardt Bio AG, was first approved by FDA on Oct 8, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2009
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 8, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Risperidone1MG/ML · solution;oral	Risperidone	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 29, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 29, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Apr 25, 2011	Supplement 1Labeling	Approved	None posted
Oct 8, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78744
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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