Application 200179
- Type
- NDA
- Sponsor
- BAYER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STAXYN | VARDENAFIL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0822 | Staxyn | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0822 | Staxyn | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0822 | Staxyn | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
| 0173-0822 | Staxyn | vardenafil hydrochloride | GlaxoSmithKline LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74057 | SUPPL | 2023-04-25 |
| 74055 | SUPPL | 2023-04-25 |
| 49573 | SUPPL | 2017-08-29 |
| 49448 | SUPPL | 2017-08-17 |
| 49245 | SUPPL | 2017-08-04 |
| 49239 | SUPPL | 2017-08-04 |
| 40013 | SUPPL | 2015-09-23 |
| 32014 | SUPPL | 2015-09-17 |
| 18952 | SUPPL | 2014-05-02 |
| 9807 | SUPPL | 2014-04-30 |
| 40012 | SUPPL | 2013-08-06 |
| 9806 | SUPPL | 2013-08-05 |
| 43343 | ORIG | 2011-01-04 |
| 40011 | ORIG | 2010-06-24 |
| 32013 | ORIG | 2010-06-21 |