Application 018211
- Type
- NDA
- Sponsor
- ORTHO MCNEIL JANSSEN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DITROPAN | OXYBUTYNIN CHLORIDE | SYRUP;ORAL | 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40783 | SUPPL | 2009-09-14 |
| 20113 | SUPPL | 2009-09-14 |
| 33458 | SUPPL | 2008-02-14 |
| 14947 | SUPPL | 2008-02-13 |
| 875 | SUPPL | 2003-05-29 |
| 33457 | SUPPL | 2003-04-16 |
| 11183 | SUPPL | 2003-04-16 |