Paragard T 380a

Prevents pregnancy in females of reproductive potential for up to 10 years. NDA 18680, held by Coopersurgical. Copper.

As of Nov 14, 2026, NDA 18680 (Paragard T 380a), held by Coopersurgical, was first approved by FDA on Nov 15, 1984, with 54 approved supplements and 0 published complete response letters.

First approved: Nov 15, 1984
Review: Standard
Supplements approved: 54
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 55 submissions below


Jun 28, 2024	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 1, 2005	Supplement 60Efficacy (new indication or use)	Approved	Label Letter
May 19, 1994	Supplement 26Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 13, 1991	Supplement 16Efficacy (new indication or use)	Approved	None posted
Jul 17, 1989	Supplement 8Efficacy (new indication or use)	Approved	None posted
Nov 15, 1984	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Paragard T 380a309MG/COPPER · system;intrauterine	Copper	RxReference drug

All 55 submissions, including labeling and manufacturing supplements


Oct 13, 2026	Supplement 77Labeling · Standard review	Approved	Label Letter
Jun 28, 2024	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 5, 2019	Supplement 70Labeling · Standard review	Approved	Label Letter
Sep 5, 2019	Supplement 69Labeling · Standard review	Approved	Label Letter
Feb 20, 2014	Supplement 68Manufacturing · Standard review	Approved	None posted
Jun 11, 2013	Supplement 66Labeling	Approved	Label Letter
Sep 1, 2005	Supplement 60Efficacy (new indication or use)	Approved	Label Letter
Apr 22, 2003	Supplement 57Labeling · Standard review	Approved	Letter
Sep 27, 2001	Supplement 56Manufacturing · Standard review	Approved	None posted
Aug 24, 2001	Supplement 55Labeling · Standard review	Approved	Label
Sep 20, 2000	Supplement 54Manufacturing · Standard review	Approved	None posted
Apr 25, 2000	Supplement 53Manufacturing · Standard review	Approved	None posted
Mar 27, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Dec 14, 1999	Supplement 51Manufacturing · Standard review	Approved	None posted
Jul 23, 1999	Supplement 50Manufacturing · Standard review	Approved	None posted
Jul 23, 1999	Supplement 49Manufacturing · Standard review	Approved	None posted
Feb 2, 1999	Supplement 48Manufacturing · Standard review	Approved	None posted
Feb 2, 1999	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 7, 1998	Supplement 44Manufacturing · Standard review	Approved	None posted
Jul 7, 1998	Supplement 43Manufacturing · Standard review	Approved	None posted
May 29, 1998	Supplement 46Manufacturing · Standard review	Approved	None posted
May 29, 1998	Supplement 45Manufacturing · Standard review	Approved	None posted
Feb 10, 1998	Supplement 42Manufacturing · Standard review	Approved	None posted
Nov 3, 1997	Supplement 41Manufacturing · Standard review	Approved	None posted
Oct 9, 1997	Supplement 40Manufacturing · Standard review	Approved	None posted
Jun 4, 1997	Supplement 39Manufacturing · Standard review	Approved	None posted
Mar 13, 1997	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 14, 1997	Supplement 37Manufacturing · Standard review	Approved	None posted
May 17, 1996	Supplement 36Manufacturing · Standard review	Approved	None posted
Apr 12, 1996	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 12, 1996	Supplement 34Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 18, 1996	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 24, 1995	Supplement 31Labeling · Standard review	Approved	None posted
Jul 24, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
May 19, 1994	Supplement 26Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 17, 1993	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 25, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 25, 1991	Supplement 23Labeling	Approved	None posted
Nov 25, 1991	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 25, 1991	Supplement 19Manufacturing · Standard review	Approved	None posted
Nov 20, 1991	Supplement 21Labeling	Approved	None posted
Aug 13, 1991	Supplement 16Efficacy (new indication or use)	Approved	None posted
Jul 17, 1991	Supplement 17Manufacturing · Standard review	Approved	None posted
May 3, 1991	Supplement 15Labeling	Approved	None posted
Mar 22, 1991	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 24, 1990	Supplement 12Labeling	Approved	None posted
Jul 24, 1989	Supplement 10Labeling	Approved	None posted
Jul 24, 1989	Supplement 11Labeling	Approved	None posted
Jul 17, 1989	Supplement 8Efficacy (new indication or use)	Approved	None posted
Mar 1, 1989	Supplement 9Labeling	Approved	None posted
Nov 18, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 17, 1988	Supplement 6Labeling	Approved	None posted
Apr 29, 1988	Supplement 3Labeling	Approved	None posted
Nov 15, 1984	Original applicationNew dosage form · Standard review	Approved	Review

Show all 55

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: ParaGardJul 25, 2019

Identifiers

Application: NDA 18680
Drugs@FDA: Overview at FDA
Company: CooperSurgical

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