Risperidone

ANDA 77719, held by Pharm Assoc. Risperidone.

As of Nov 14, 2026, ANDA 77719 (Risperidone), held by Pharm Assoc, was first approved by FDA on Jul 29, 2009, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2009
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
Jul 29, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Risperidone1MG/ML · solution;oral	Risperidone	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Dec 27, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Dec 27, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jan 6, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Jun 27, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Oct 25, 2012	Supplement 3Labeling · Standard review	Approved	None posted
Jan 30, 2012	Supplement 2Labeling	Approved	None posted
Jul 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77719
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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