← FDA DRUG APPROVALS

FDA ANDA · ANDA206936

GLATIRAMER ACETATE

glatiramer

Sponsor: MYLAN

APPLICATION
ANDA206936
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-03
LATEST ACTION
2024-02-15
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GLATIRAMER ACETATEPrescription
GLATIRAMER ACETATE 40MG/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2024-02-15Labeling · Supplement 19 · standardAP
2024-02-15Labeling · Supplement 20 · standardAP
2022-08-19Labeling · Supplement 17 · standardAP
2022-08-19Labeling · Supplement 8 · standardAP
2022-08-19Labeling · Supplement 4 · standardAP
2022-08-19Labeling · Supplement 11 · standardAP
2022-08-19Labeling · Supplement 9 · standardAP
2022-08-19Labeling · Supplement 16 · standardAP
2022-08-19Labeling · Supplement 7 · standardAP
2017-10-03UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →