Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090218
Company: SANDOZ

Products on ANDA 090218

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090218

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2015	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090218Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090218Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/090218Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2024	SUPPL-28	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/08/2023	SUPPL-27	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.
09/21/2022	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-21	Labeling-Package Insert, Labeling-Patient 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-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/09/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/09/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 090218

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090218Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 090218

GLATOPA

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	091646	MYLAN
GLATOPA	GLATIRAMER ACETATE	20MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	No	AP	090218	SANDOZ