Risperidone

ANDA 78464, held by Sun Pharm Inds Ltd. Risperidone.

As of Nov 13, 2026, ANDA 78464 (Risperidone), held by Sun Pharm Inds Ltd, was first approved by FDA on Apr 8, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 8, 2013	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 3 submissions, including labeling and manufacturing supplements


Oct 20, 2026	Supplement 14Labeling · Standard review	Approved	None posted
Jan 5, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Apr 8, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 78464
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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