← FDA DRUG APPROVALS

FDA NDA · NDA020622

COPAXONE

glatiramer acetate

Sponsor: TEVA PHARMS USA

APPLICATION
NDA020622
TYPE
NDA
ORIGINAL APPROVAL
1996-12-20
LATEST ACTION
2026-06-22
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE, FOR SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

COPAXONE · ReferencePrescription
GLATIRAMER ACETATE 20MG/ML · INJECTABLE · SUBCUTANEOUS
COPAXONE · ReferencePrescription
GLATIRAMER ACETATE 40MG/ML · INJECTABLE · SUBCUTANEOUS
COPAXONE · ReferenceDiscontinued
GLATIRAMER ACETATE 20MG/VIAL · FOR SOLUTION · SUBCUTANEOUS

Approval history

2026-06-22Labeling · Supplement 121 · standard — Label ↗AP
2025-01-22Labeling · Supplement 118 · standard — Label ↗AP
2025-01-22Labeling · Supplement 119 · standard — Label ↗AP
2023-11-16Labeling · Supplement 116 · standard — Label ↗AP
2023-01-04Labeling · Supplement 115 · standard — Letter ↗AP
2022-04-15Labeling · Supplement 114 · standard — Letter ↗AP
2022-01-28Labeling · Supplement 113 · standard — Letter ↗AP
2020-07-22Labeling · Supplement 110 · standard — Label ↗AP
2020-05-14Labeling · Supplement 109 · standard — Letter ↗AP
2019-12-27Labeling · Supplement 107 · standard — Letter ↗AP
2019-07-19Labeling · Supplement 106 · standard — Label ↗AP
2018-09-07Labeling · Supplement 104 · standard — Label ↗AP
2018-01-23Labeling · Supplement 102 · standard — Label ↗AP
2016-11-18Manufacturing (CMC) · Supplement 99 · standardAP
2016-11-15Manufacturing (CMC) · Supplement 98 · standardAP
2016-03-14Manufacturing (CMC) · Supplement 93 · standardAP
2015-12-03Manufacturing (CMC) · Supplement 95 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 96 · standardAP
2015-08-03Manufacturing (CMC) · Supplement 94 · standardAP
2015-01-26Manufacturing (CMC) · Supplement 92 · standardAP
2014-01-28Efficacy · Supplement 89 · standard — Review ↗AP
2013-12-06Manufacturing (CMC) · Supplement 91 · standardAP
2013-09-05Manufacturing (CMC) · Supplement 85 · standardAP
2013-09-05Manufacturing (CMC) · Supplement 83 · standardAP
2013-03-08Manufacturing (CMC) · Supplement 87 · standard — Label ↗AP
2013-02-22Manufacturing (CMC) · Supplement 79 · standardAP
2009-02-27Efficacy · Supplement 57 · unknown — Label ↗AP
2002-08-29Labeling · Supplement 26 · standard — Letter ↗AP
2002-05-20Manufacturing (CMC) · Supplement 25 · standardAP
2002-03-11Manufacturing (CMC) · Supplement 24 · standardAP
2002-02-12Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2001-07-12Labeling · Supplement 15 · standard — Review ↗AP
2001-06-12Labeling · Supplement 22 · standardAP
2001-02-28Labeling · Supplement 20 · standardAP
2001-02-23Manufacturing (CMC) · Supplement 19 · standardAP
2001-01-25Manufacturing (CMC) · Supplement 18 · standardAP
2000-08-09Labeling · Supplement 7 · standardAP
2000-07-06Labeling · Supplement 9 · standardAP
2000-07-06Labeling · Supplement 4 · standardAP
1999-11-29Manufacturing (CMC) · Supplement 17 · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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