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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 214741

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NDA 214741 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 214741

Tradename:	GLATIRAMER ACETATE
Applicant:	Scinopharm Taiwan
Ingredient:	glatiramer acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 214741

Adjuvants, Immunologic
Antirheumatic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 214741

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	214741	ANDA	UPSHER-SMITH LABORATORIES, LLC	0832-6084	0832-6084-30	30 SYRINGE, GLASS in 1 CARTON (0832-6084-30) / 1 mL in 1 SYRINGE, GLASS (0832-6084-89)
GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	214741	ANDA	UPSHER-SMITH LABORATORIES, LLC	0832-6085	0832-6085-12	12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	20MG/ML
Approval Date:	Dec 31, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	40MG/ML
Approval Date:	Dec 31, 2025	TE:	AP	RLD:	No

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