Risperidone

ANDA 205104, held by Ipca Labs Ltd. Risperidone.

As of Nov 13, 2026, ANDA 205104 (Risperidone), held by Ipca Labs Ltd, was first approved by FDA on Jun 26, 2024, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 26, 2024
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 26, 2024	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 2 submissions, including labeling and manufacturing supplements


Apr 9, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Jun 26, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 205104
Drugs@FDA: Overview at FDA
Company: Ipca 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