Application 020622
- Type
- NDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COPAXONE | GLATIRAMER ACETATE | FOR SOLUTION;SUBCUTANEOUS | 20MG/VIAL | No | No |
| 002 | COPAXONE | GLATIRAMER ACETATE | INJECTABLE;SUBCUTANEOUS | 20MG/ML | Yes | Yes |
| 003 | COPAXONE | GLATIRAMER ACETATE | INJECTABLE;SUBCUTANEOUS | 40MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-317 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
| 68546-325 | Copaxone | Glatiramer Acetate | Teva Neuroscience, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82808 | SUPPL | 2025-07-11 |
| 82801 | SUPPL | 2025-07-11 |
| 82800 | SUPPL | 2025-07-11 |
| 81141 | SUPPL | 2025-02-07 |
| 81139 | SUPPL | 2025-02-07 |
| 80929 | SUPPL | 2025-02-05 |
| 80928 | SUPPL | 2025-02-05 |
| 80927 | SUPPL | 2025-02-05 |
| 76614 | SUPPL | 2023-11-17 |
| 76608 | SUPPL | 2023-11-17 |
| 73108 | SUPPL | 2023-01-06 |
| 73093 | SUPPL | 2023-01-05 |
| 70782 | SUPPL | 2022-04-18 |
| 70779 | SUPPL | 2022-04-18 |
| 70035 | SUPPL | 2022-02-01 |
| 70005 | SUPPL | 2022-01-31 |
| 64086 | SUPPL | 2020-07-24 |
| 64043 | SUPPL | 2020-07-23 |
| 63027 | SUPPL | 2020-05-15 |
| 61494 | SUPPL | 2020-01-02 |
| 61471 | SUPPL | 2019-12-30 |
| 59393 | SUPPL | 2019-07-22 |
| 59391 | SUPPL | 2019-07-22 |
| 57676 | ORIG | 2019-02-15 |
| 55439 | SUPPL | 2018-09-12 |
| 55418 | SUPPL | 2018-09-10 |
| 51899 | SUPPL | 2018-01-26 |
| 51846 | SUPPL | 2018-01-26 |
| 45785 | SUPPL | 2016-11-02 |
| 12856 | SUPPL | 2014-01-31 |
| 2891 | SUPPL | 2014-01-29 |
| 34966 | SUPPL | 2013-03-12 |
| 12855 | SUPPL | 2009-03-17 |
| 25331 | SUPPL | 2009-03-03 |
| 41485 | SUPPL | 2007-04-09 |
| 34965 | SUPPL | 2003-04-28 |
| 2890 | SUPPL | 2002-08-29 |
| 2889 | SUPPL | 2002-02-12 |