Drugs@FDA: FDA Approved Drug Products

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

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 PHARMS INC
GLATOPA GLATIRAMER ACETATE 20MG/ML INJECTABLE;SUBCUTANEOUS Prescription No AP 090218 SANDOZ INC

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