Risperidone

ANDA 76879, held by Dr Reddys Labs Ltd. Risperidone.

As of Nov 14, 2026, ANDA 76879 (Risperidone), held by Dr Reddys Labs Ltd, was first approved by FDA on Oct 24, 2008, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 24, 2008
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 24, 2008	Original application	Approved	None posted

Products

6 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Aug 27, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Jan 5, 2012	Supplement 8Labeling	Approved	None posted
Jan 5, 2012	Supplement 7Labeling	Approved	None posted
Oct 26, 2011	Supplement 6Labeling	Approved	None posted
Aug 3, 2011	Supplement 5Labeling	Approved	None posted
May 27, 2011	Supplement 4Labeling	Approved	None posted
Dec 29, 2010	Supplement 3Labeling	Approved	None posted
Feb 2, 2010	Supplement 1Labeling	Approved	None posted
Oct 24, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 76879
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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