Nisoldipine

As of Nov 15, 2026, ANDA 91001 (Nisoldipine), held by Mylan, was first approved by FDA on Jan 26, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 26, 2011
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
Jan 26, 2011	Original application	Approved	Letter

Products

4 strengths and forms


Nisoldipine8.5MG · tablet, extended release;oral	Nisoldipine	Discontinued
Nisoldipine17MG · tablet, extended release;oral	Nisoldipine	Discontinued
Nisoldipine25.5MG · tablet, extended release;oral	Nisoldipine	Discontinued
Nisoldipine34MG · tablet, extended release;oral	Nisoldipine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 11, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Jan 26, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 91001
Drugs@FDA: Overview at FDA
Company: Mylan

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