APPLICATION
ANDA206921
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-12
LATEST ACTION
2026-02-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
GLATOPAPrescription
GLATIRAMER ACETATE 40MG/ML · INJECTABLE · SUBCUTANEOUS
Approval history
2026-02-12Labeling · Supplement 33 · standardAP
2025-03-07Labeling · Supplement 32 · standardAP
2024-03-19Labeling · Supplement 29 · standardAP
2023-07-05Labeling · Supplement 28 · standardAP
2022-09-21Labeling · Supplement 26 · standardAP
2022-09-21Labeling · Supplement 25 · standardAP
2020-11-09Labeling · Supplement 18 · standardAP
2020-11-09Labeling · Supplement 22 · standardAP
2020-11-09Labeling · Supplement 20 · standardAP
2020-11-09Labeling · Supplement 8 · standardAP
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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