Risperidone

ANDA 78871, held by Novitium Pharma. Risperidone.

As of Nov 14, 2026, ANDA 78871 (Risperidone), held by Novitium Pharma, was first approved by FDA on Oct 9, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 9, 2008
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
Oct 9, 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 9 submissions, including labeling and manufacturing supplements


Jun 29, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Nov 6, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Nov 12, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Jan 3, 2012	Supplement 4Labeling	Approved	None posted
Jun 20, 2011	Supplement 3Labeling	Approved	None posted
Apr 8, 2011	Supplement 2Labeling	Approved	None posted
Oct 9, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78871
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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