Quinidine Gluconate

ANDA 87810, held by Ani Pharms. Quinidine Gluconate.

As of Nov 15, 2026, ANDA 87810 (Quinidine Gluconate), held by Ani Pharms, was first approved by FDA on Sep 29, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1982
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 29, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 15 submissions, including labeling and manufacturing supplements


Jan 8, 2001	Supplement 21Labeling	Approved	None posted
Apr 30, 1999	Supplement 20Labeling	Approved	None posted
Oct 8, 1998	Supplement 18Manufacturing	Approved	None posted
Jul 16, 1996	Supplement 17Labeling	Approved	None posted
Apr 14, 1992	Supplement 13Labeling	Approved	None posted
Jan 10, 1992	Supplement 12Labeling	Approved	None posted
Aug 12, 1991	Supplement 10Manufacturing	Approved	None posted
Aug 7, 1991	Supplement 8Manufacturing	Approved	None posted
Jul 2, 1991	Supplement 11Labeling	Approved	None posted
Jan 28, 1991	Supplement 9Manufacturing	Approved	None posted
Mar 18, 1988	Supplement 5Manufacturing	Approved	None posted
Mar 17, 1988	Supplement 6Manufacturing	Approved	None posted
Nov 8, 1983	Supplement 2Manufacturing	Approved	None posted
Nov 1, 1982	Supplement 1Manufacturing	Approved	None posted
Sep 29, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87810
Drugs@FDA: Overview at FDA
Company: ANI 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