Application 021336
- Type
- NDA
- Sponsor
- SOMERSET
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMSAM | SELEGILINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 6MG/24HR | Yes | Yes |
| 002 | EMSAM | SELEGILINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 9MG/24HR | Yes | No |
| 003 | EMSAM | SELEGILINE | FILM, EXTENDED RELEASE;TRANSDERMAL | 12MG/24HR | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 49502-900 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-900 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-900 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-901 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-901 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-901 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-902 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-902 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
| 49502-902 | EMSAM | selegiline | Mylan Specialty L.P. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49013 | SUPPL | 2017-07-18 |
| 49012 | SUPPL | 2017-07-18 |
| 49003 | SUPPL | 2017-07-17 |
| 36682 | SUPPL | 2015-04-01 |
| 27509 | SUPPL | 2015-04-01 |
| 36681 | SUPPL | 2014-09-30 |
| 27508 | SUPPL | 2014-09-16 |
| 5070 | SUPPL | 2014-09-16 |
| 5069 | SUPPL | 2008-02-14 |
| 21607 | ORIG | 2007-09-10 |
| 27507 | SUPPL | 2007-08-02 |
| 15210 | SUPPL | 2007-07-31 |
| 23645 | ORIG | 2007-05-09 |
| 36680 | ORIG | 2006-03-03 |
| 27506 | ORIG | 2006-03-03 |
| 51656 | SUPPL | 1900-01-01 |
| 51654 | SUPPL | 1900-01-01 |
| 51653 | SUPPL | 1900-01-01 |
| 51652 | SUPPL | 1900-01-01 |