Copaxone

Treats relapsing forms of multiple sclerosis (MS). NDA 20622, held by Teva Pharms USA. Glatiramer Acetate.

As of Nov 13, 2026, NDA 20622 (Copaxone), held by Teva Pharms USA, was first approved by FDA on Dec 20, 1996, with 52 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1996
Review: Standard
Supplements approved: 52
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 53 submissions below


Jan 28, 2014	Supplement 89Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 27, 2009	Supplement 57Efficacy (new indication or use)	Approved	Label Letter
Dec 20, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


Copaxone20MG/VIAL · for solution;subcutaneous	Glatiramer Acetate	DiscontinuedReference drug
Copaxone20MG/ML · injectable;subcutaneous	Glatiramer Acetate	RxReference drug
Copaxone40MG/ML · injectable;subcutaneous	Glatiramer Acetate	RxReference drug

All 53 submissions, including labeling and manufacturing supplements


Jun 22, 2026	Supplement 121Labeling · Standard review	Approved	Letter Label
Jan 22, 2025	Supplement 118Labeling · Standard review	Approved	Review Letter Label
Jan 22, 2025	Supplement 119Labeling · Standard review	Approved	Review Review Letter Label
Nov 16, 2023	Supplement 116Labeling · Standard review	Approved	Label Letter
Jan 4, 2023	Supplement 115Labeling · Standard review	Approved	Label Letter
Apr 15, 2022	Supplement 114Labeling · Standard review	Approved	Letter Label
Jan 28, 2022	Supplement 113Labeling · Standard review	Approved	Label Letter
Jul 22, 2020	Supplement 110Labeling · Standard review	Approved	Letter Label
May 14, 2020	Supplement 109Labeling · Standard review	Approved	Letter
Dec 27, 2019	Supplement 107Labeling · Standard review	Approved	Label Letter
Jul 19, 2019	Supplement 106Labeling · Standard review	Approved	Label Letter
Sep 7, 2018	Supplement 104Labeling · Standard review	Approved	Letter Label
Jan 23, 2018	Supplement 102Labeling · Standard review	Approved	Label Letter
Nov 18, 2016	Supplement 99Manufacturing · Standard review	Approved	None posted
Nov 15, 2016	Supplement 98Manufacturing · Standard review	Approved	None posted
Mar 14, 2016	Supplement 93Manufacturing · Standard review	Approved	None posted
Dec 3, 2015	Supplement 95Manufacturing · Standard review	Approved	None posted
Oct 2, 2015	Supplement 96Manufacturing · Standard review	Approved	None posted
Aug 3, 2015	Supplement 94Manufacturing · Standard review	Approved	None posted
Jan 26, 2015	Supplement 92Manufacturing · Standard review	Approved	None posted
Jan 28, 2014	Supplement 89Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 6, 2013	Supplement 91Manufacturing · Standard review	Approved	None posted
Sep 5, 2013	Supplement 83Manufacturing · Standard review	Approved	None posted
Sep 5, 2013	Supplement 85Manufacturing · Standard review	Approved	None posted
Mar 8, 2013	Supplement 87Manufacturing · Standard review	Approved	Label
Feb 22, 2013	Supplement 79Manufacturing · Standard review	Approved	None posted
Feb 27, 2009	Supplement 57Efficacy (new indication or use)	Approved	Label Letter
Aug 29, 2002	Supplement 26Labeling · Standard review	Approved	Letter
May 20, 2002	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 11, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 12, 2002	Supplement 23Manufacturing · Standard review	Approved	Letter
Jul 12, 2001	Supplement 15Labeling · Standard review	Approved	Review Label
Jun 12, 2001	Supplement 22Labeling · Standard review	Approved	None posted
Feb 28, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Feb 23, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 25, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 9, 2000	Supplement 7Labeling · Standard review	Approved	None posted
Jul 6, 2000	Supplement 9Labeling · Standard review	Approved	None posted
Jul 6, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Nov 29, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 24, 1999	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 16, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 16, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 4, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 3, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 30, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 28, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 25, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 16, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 23, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 23, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 4, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Show all 53

Identifiers

Application: NDA 20622
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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