Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206936
Company: MYLAN

Products on ANDA 206936

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 206936

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206936Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-20	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
02/15/2024	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-16	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/19/2022	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206936

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	206936	MYLAN
GLATOPA	GLATIRAMER ACETATE	40MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	206921	SANDOZ