Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020622
Company: TEVA PHARMS USA
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 | Yes | 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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020622Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-116 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020622Orig1s116ltr.pdf | |
| 01/04/2023 | SUPPL-115 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020622Orig1s115ltr.pdf | |
| 04/15/2022 | SUPPL-114 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020622s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020622Orig1s114ltr.pdf | |
| 01/28/2022 | SUPPL-113 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020622s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020622Orig1s113ltr.pdf | |
| 07/22/2020 | SUPPL-110 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020622s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020622Orig1s110ltr.pdf | |
| 05/14/2020 | SUPPL-109 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020622Orig1s109ltr.pdf |
| 12/27/2019 | SUPPL-107 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020622s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020622Orig1s107ltr.pdf | |
| 07/19/2019 | SUPPL-106 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020622s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020622Orig1s106ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s116lbl.pdf | |
| 01/04/2023 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020622s115lbl.pdf | |
| 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-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 |
| GLATIRAMER ACETATE | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 203857 | SYNTHON PHARMS INC |
| GLATOPA | GLATIRAMER ACETATE | 20MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 090218 | SANDOZ |
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 |
| GLATIRAMER ACETATE | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206873 | SYNTHON PHARMS INC |
| GLATOPA | GLATIRAMER ACETATE | 40MG/ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206921 | SANDOZ |