Quinidine Gluconate

ANDA 89894, held by Rising. Quinidine Gluconate.

As of Nov 15, 2026, ANDA 89894 (Quinidine Gluconate), held by Rising, was first approved by FDA on Dec 15, 1988, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 15, 1988
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 15, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Quinidine Gluconate324MG · tablet, extended release;oral	Quinidine Gluconate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 9, 2001	Supplement 8Manufacturing	Approved	None posted
Jun 29, 1999	Supplement 6Manufacturing	Approved	None posted
Jun 29, 1999	Supplement 7Labeling	Approved	None posted
Nov 20, 1997	Supplement 5Labeling	Approved	None posted
Apr 6, 1995	Supplement 4Manufacturing	Approved	None posted
Nov 2, 1992	Supplement 3Labeling	Approved	None posted
Dec 15, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89894
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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