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 |
| 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 |