Diltiazem Hydrochloride

ANDA 91022, held by Chartwell Rx. Diltiazem Hydrochloride.

As of Nov 15, 2026, ANDA 91022 (Diltiazem Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 28, 2012, with 0 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2012
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Sep 28, 2012	Original application	Approved	None posted

Products

6 strengths and forms


Diltiazem Hydrochloride120MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx
Diltiazem Hydrochloride180MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx
Diltiazem Hydrochloride240MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx
Diltiazem Hydrochloride300MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx
Diltiazem Hydrochloride360MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx
Diltiazem Hydrochloride420MG · capsule, extended release;oral	Diltiazem Hydrochloride	Rx

Identifiers

Application: ANDA 91022
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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