Norvasc

Treats hypertension. NDA 19787, held by Viatris. Amlodipine Besylate.

As of Nov 13, 2026, NDA 19787 (Norvasc), held by Viatris, was first approved by FDA on Jul 31, 1992, with 45 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1992
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

Hypertension o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Coronary Artery Disease o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below

Date	Submission	Status	Documents
Sep 28, 2005	Supplement 38Efficacy (new indication or use)	Approved	Letter Label
Jan 8, 2004	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Review Letter
Jul 12, 2000	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jun 14, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review
Jul 31, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
NorvascEQ 2.5MG BASE · tablet;oral	Amlodipine Besylate	RxReference drug
NorvascEQ 5MG BASE · tablet;oral	Amlodipine Besylate	RxReference drug
NorvascEQ 10MG BASE · tablet;oral	Amlodipine Besylate	RxReference drug

All 46 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 30, 2017	Supplement 62Labeling · Standard review	Approved	Label Letter
Mar 30, 2017	Supplement 61Labeling · Standard review	Approved	Letter Label
Mar 23, 2015	Supplement 59Labeling · Standard review	Approved	Label Letter
Jul 28, 2014	Supplement 58Manufacturing · Standard review	Approved	None posted
Sep 12, 2013	Supplement 56Manufacturing · Standard review	Approved	None posted
Jul 24, 2013	Supplement 57Manufacturing · Standard review	Approved	None posted
Jan 7, 2013	Supplement 54Labeling	Approved	Letter Label
Jan 7, 2013	Supplement 53Labeling	Approved	Letter Label
Nov 16, 2012	Supplement 55Manufacturing · Standard review	Approved	None posted
Oct 31, 2011	Supplement 52Labeling	Approved	Letter Label
May 9, 2011	Supplement 47Labeling	Approved	Letter Label
Feb 17, 2010	Supplement 45Labeling · Standard review	Approved	Label Letter
Oct 31, 2007	Supplement 42Labeling · Standard review	Approved	Letter Label
Sep 28, 2005	Supplement 38Efficacy (new indication or use)	Approved	Letter Label
Jul 13, 2005	Supplement 37Labeling · Standard review	Approved	Letter Label
Jan 8, 2004	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 3, 2003	Supplement 27Labeling · Standard review	Approved	Letter
Aug 20, 2003	Supplement 31Labeling · Standard review	Approved	Letter
May 28, 2002	Supplement 32Labeling · Standard review	Approved	Letter
Aug 13, 2001	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 10, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 6, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 12, 2000	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Review
Jul 12, 2000	Supplement 17Labeling · Standard review	Approved	Letter Review
Mar 14, 2000	Supplement 23Labeling · Standard review	Approved	None posted
Feb 23, 2000	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 1, 2000	Supplement 21Manufacturing · Standard review	Approved	Review
Dec 15, 1999	Supplement 22Manufacturing · Standard review	Approved	Review
Sep 7, 1999	Supplement 19Manufacturing · Standard review	Approved	Letter Review
Jun 4, 1999	Supplement 18Manufacturing · Standard review	Approved	Review
Mar 9, 1998	Supplement 16Manufacturing · Standard review	Approved	Review
May 16, 1997	Supplement 15Manufacturing · Standard review	Approved	Review
Apr 18, 1997	Supplement 14Manufacturing · Standard review	Approved	Review
Jan 8, 1997	Supplement 13Labeling · Standard review	Approved	Review
Jun 28, 1996	Supplement 12Manufacturing · Standard review	Approved	Review
Jun 14, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review
Feb 8, 1996	Supplement 10Manufacturing · Standard review	Approved	Review
Feb 7, 1996	Supplement 11Manufacturing · Standard review	Approved	Review
Dec 5, 1995	Supplement 9Labeling · Standard review	Approved	Review
Nov 2, 1995	Supplement 8Manufacturing · Standard review	Approved	Review
Jun 19, 1995	Supplement 6Manufacturing · Standard review	Approved	Review
Feb 7, 1995	Supplement 5Manufacturing · Standard review	Approved	Review
Jan 12, 1995	Supplement 2Labeling · Standard review	Approved	Review
May 3, 1994	Supplement 4Manufacturing · Standard review	Approved	Review
Mar 3, 1994	Supplement 3Manufacturing · Standard review	Approved	Review
Jul 31, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19787
Drugs@FDA: Overview at FDA
Company: Viatris

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