Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091646
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLATIRAMER ACETATE 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
10/03/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091646Orig1s000ltr.pdf

GLATIRAMER ACETATE

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 INC

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