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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020622
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COPAXONE GLATIRAMER ACETATE 20MG/VIAL FOR SOLUTION;SUBCUTANEOUS Discontinued None No No
COPAXONE GLATIRAMER ACETATE 20MG/ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
COPAXONE GLATIRAMER ACETATE 40MG/ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/15/2022 SUPPL-114 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020622s114lbl.pdf
01/28/2022 SUPPL-113 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020622s113lbl.pdf
07/22/2020 SUPPL-110 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020622s110lbl.pdf
12/27/2019 SUPPL-107 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020622s107lbl.pdf
07/19/2019 SUPPL-106 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020622s106lbl.pdf
09/07/2018 SUPPL-104 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s104lbl.pdf
09/07/2018 SUPPL-104 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s104lbl.pdf
01/23/2018 SUPPL-102 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s102lbl.pdf
01/23/2018 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s102lbl.pdf
01/28/2014 SUPPL-89 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf
03/08/2013 SUPPL-87 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020622s087lbl.pdf
02/27/2009 SUPPL-57 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf
07/12/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf
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