Application 017577
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DITROPAN | OXYBUTYNIN CHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 646 | SUPPL | 2012-03-26 |
| 11034 | SUPPL | 2012-03-23 |
| 13858 | SUPPL | 2011-12-20 |
| 11033 | SUPPL | 2011-12-20 |
| 13857 | SUPPL | 2011-08-10 |
| 11032 | SUPPL | 2011-08-08 |
| 40752 | SUPPL | 2009-09-14 |
| 20080 | SUPPL | 2009-09-14 |
| 11031 | SUPPL | 2009-07-23 |
| 645 | SUPPL | 2009-07-16 |
| 11030 | SUPPL | 2008-02-14 |
| 13856 | SUPPL | 2008-02-13 |
| 13855 | SUPPL | 2003-05-29 |
| 33307 | SUPPL | 2003-04-16 |
| 11029 | SUPPL | 2003-04-16 |