Application 022250
- Type
- NDA
- Sponsor
- ACORDA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPYRA | DALFAMPRIDINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0509 | dalfampridine | dalfampridine | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-0509 | dalfampridine | dalfampridine | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 10144-427 | AMPYRA | Dalfampridine | Acorda Therapeutics, Inc. | NDA | Current |
| 10144-427 | AMPYRA | Dalfampridine | Acorda Therapeutics, Inc. | NDA | Current |
| 10144-427 | AMPYRA | Dalfampridine | Acorda Therapeutics, Inc. | NDA | Current |
| 10144-427 | AMPYRA | Dalfampridine | Acorda Therapeutics, Inc. | NDA | Current |
| 10144-427 | AMPYRA | Dalfampridine | Acorda Therapeutics, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69367 | SUPPL | 2021-11-22 |
| 69358 | SUPPL | 2021-11-19 |
| 69357 | SUPPL | 2021-11-19 |
| 66402 | SUPPL | 2021-02-26 |
| 66399 | SUPPL | 2021-02-26 |
| 66359 | SUPPL | 2021-02-25 |
| 61397 | SUPPL | 2019-12-23 |
| 61371 | SUPPL | 2019-12-20 |
| 61370 | SUPPL | 2019-12-20 |
| 56228 | SUPPL | 2018-11-01 |
| 49929 | SUPPL | 2017-10-03 |
| 49928 | SUPPL | 2017-10-03 |
| 49915 | SUPPL | 2017-10-03 |
| 45617 | SUPPL | 2016-10-17 |
| 45547 | SUPPL | 2016-10-17 |
| 29446 | SUPPL | 2013-06-20 |
| 29444 | SUPPL | 2013-01-24 |
| 17123 | SUPPL | 2013-01-23 |
| 17124 | SUPPL | 2013-01-11 |
| 29445 | SUPPL | 2012-12-26 |
| 7090 | SUPPL | 2012-07-24 |
| 38424 | SUPPL | 2012-07-23 |
| 23703 | ORIG | 2012-07-23 |
| 17122 | SUPPL | 2012-07-23 |
| 7089 | SUPPL | 2011-11-21 |
| 42465 | ORIG | 2010-02-23 |
| 29443 | ORIG | 2010-01-29 |
| 17121 | ORIG | 2010-01-24 |