Covera-Hs

NDA 20552, held by Pfizer. Verapamil Hydrochloride.

As of Nov 13, 2026, NDA 20552 (Covera-Hs), held by Pfizer, was first approved by FDA on Feb 26, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1996
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 26, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Covera-Hs180MG · tablet, extended release;oral	Verapamil Hydrochloride	Discontinued
Covera-Hs240MG · tablet, extended release;oral	Verapamil Hydrochloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 14, 2017	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 24, 2016	Supplement 9Labeling · Standard review	Approved	Letter
Nov 2, 2011	Supplement 7Labeling	Approved	Letter Label
Apr 13, 2010	Supplement 6Labeling	Approved	Label Letter
Jun 29, 2009	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 31, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Jan 13, 1998	Supplement 1Labeling · Standard review	Approved	None posted
Feb 26, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20552
Drugs@FDA: Overview at FDA
Company: Pfizer

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