Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206873
Company: SYNTHON PHARMS INC

Products on ANDA 206873

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2025	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206873

GLATIRAMER ACETATE

INJECTABLE;SUBCUTANEOUS; 40MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COPAXONE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	Yes	AP	020622	TEVA PHARMS USA
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	208468	CHEMI SPA
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	214022	HYBIO
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206936	MYLAN
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	214741	SCINOPHARM TAIWAN
GLATIRAMER ACETATE	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206873	SYNTHON PHARMS INC
GLATOPA	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206921	SANDOZ