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Active ingredient

Glatiramer

18 finished FDA listings contain Glatiramer as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
GLATIRAMER, GLATIRAMER ACETATE
Dosage forms
Injection, Solution
Routes
Subcutaneous
Manufacturers / labelers
9
Strengths listed
20 mg/ml · 40 mg/ml
Brand names in FDA listings
Copaxone, Glatiramer Acetate, Glatopa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 214582

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020622TEVA PHARMS USA1996-12-202
ANDA 090218SANDOZ2015-04-162
ANDA 206936MYLAN2017-10-031
ANDA 091646MYLAN2017-10-031
ANDA 206921SANDOZ2018-02-122
ANDA 203857SYNTHON BV2024-09-251
ANDA 206873SYNTHON BV2024-09-251
ANDA 208468CHEMI SPA2025-05-074
ANDA 214741SCINOPHARM TAIWAN2025-12-312
ANDA 213382HYBIO2026-02-111
ANDA 214022HYBIO2026-02-111

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.