Application 021351
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | OXYTROL | OXYBUTYNIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 3.9MG/24HR | Yes | Yes |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78601 | SUPPL | 2024-09-06 |
| 78578 | SUPPL | 2024-05-30 |
| 50221 | SUPPL | 2017-10-30 |
| 50220 | SUPPL | 2017-10-30 |
| 50172 | SUPPL | 2017-10-25 |
| 50171 | SUPPL | 2017-10-25 |
| 15259 | SUPPL | 2015-07-13 |
| 5132 | SUPPL | 2015-07-13 |
| 36733 | SUPPL | 2012-10-12 |
| 27565 | SUPPL | 2012-10-12 |
| 15258 | SUPPL | 2012-10-12 |
| 5131 | SUPPL | 2012-10-12 |
| 5130 | SUPPL | 2011-02-03 |
| 36732 | SUPPL | 2011-01-31 |
| 5129 | SUPPL | 2006-07-13 |
| 36731 | SUPPL | 2006-07-07 |
| 42116 | ORIG | 2005-04-08 |
| 27564 | ORIG | 2003-03-10 |
| 15257 | ORIG | 2003-02-26 |