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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 214022

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NDA 214022 describes GLATIRAMER ACETATE, which is a drug marketed by Chemi Spa, Hybio, Mylan, Scinopharm Taiwan, and Synthon Pharms Inc, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the GLATIRAMER ACETATE profile page.

The generic ingredient in GLATIRAMER ACETATE is glatiramer acetate. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.

Summary for 214022

Tradename:	GLATIRAMER ACETATE
Applicant:	Hybio
Ingredient:	glatiramer acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 214022

Adjuvants, Immunologic
Antirheumatic Agents
Immunosuppressive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	40MG/ML
Approval Date:	Feb 11, 2026	TE:	AP	RLD:	No

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