Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/20/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2018 SUPPL-104 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020622Orig1s104ltr.pdf
01/23/2018 SUPPL-102 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020622Orig1s102ltr.pdf
11/18/2016 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

11/15/2016 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

12/03/2015 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/03/2015 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

03/14/2016 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

01/26/2015 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

12/06/2013 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

01/28/2014 SUPPL-89 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020622Orig1s089.pdf
03/08/2013 SUPPL-87 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020622s087lbl.pdf
09/05/2013 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

09/05/2013 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

02/22/2013 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

02/27/2009 SUPPL-57 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf
08/29/2002 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622slr026ltr.pdf
05/20/2002 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/11/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/12/2002 SUPPL-23 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622s23ltr.pdf
06/12/2001 SUPPL-22 Labeling

Label is not available on this site.

02/28/2001 SUPPL-20 Labeling

Label is not available on this site.

02/23/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/25/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/24/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/12/2001 SUPPL-15 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf
08/16/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/04/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/03/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/30/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/2000 SUPPL-9 Labeling

Label is not available on this site.

06/28/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/09/2000 SUPPL-7 Labeling

Label is not available on this site.

02/25/1999 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/06/2000 SUPPL-4 Labeling

Label is not available on this site.

01/23/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/23/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1997 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020622s102lbl.pdf
01/23/2018 SUPPL-102 Labeling-Patient 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

COPAXONE

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

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 PHARMS INC
GLATOPA GLATIRAMER ACETATE 40MG/ML INJECTABLE;SUBCUTANEOUS Prescription No AP 206921 SANDOZ INC

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