Risperidone

ANDA 78187, held by Synthon Pharms. Risperidone.

As of Nov 13, 2026, ANDA 78187 (Risperidone), held by Synthon Pharms, was first approved by FDA on Oct 22, 2009, with 0 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2009
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Oct 22, 2009	Original application	Approved	None posted

Products

6 strengths and forms


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

Identifiers

Application: ANDA 78187
Drugs@FDA: Overview at FDA
Company: Synthon

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