Last Updated: May 2, 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 six 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. Nine 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

Suppliers and Packaging for NDA: 214022

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	214022	ANDA	AJENAT PHARMACEUTICALS LLC	82983-430	82983-430-12	12 BLISTER PACK in 1 CARTON (82983-430-12) / 1 SYRINGE in 1 BLISTER PACK (82983-430-01) / 1 mL in 1 SYRINGE

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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