Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213382
Company: HYBIO

Products on ANDA 213382

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213382

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/11/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213382

GLATIRAMER ACETATE

INJECTABLE;SUBCUTANEOUS; 20MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COPAXONE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AP	020622	TEVA PHARMS USA
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	208468	CHEMI SPA
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	213382	HYBIO
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	091646	MYLAN
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	214741	SCINOPHARM TAIWAN
GLATIRAMER ACETATE	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	203857	SYNTHON PHARMS INC
GLATOPA	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	090218	SANDOZ