Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206921
Company: SANDOZ

Products on ANDA 206921

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206921Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2024	SUPPL-29	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/05/2023	SUPPL-28	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/21/2022	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/21/2022	SUPPL-25	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-22	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-18	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206921

GLATOPA

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