Application 017831
- Type
- NDA
- Sponsor
- APIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIDRONEL | ETIDRONATE DISODIUM | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | DIDRONEL | ETIDRONATE DISODIUM | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 13921 | SUPPL | 2015-04-13 |
| 11075 | SUPPL | 2015-04-10 |
| 33361 | SUPPL | 2015-03-19 |
| 720 | SUPPL | 2015-03-19 |
| 13920 | SUPPL | 2013-04-24 |
| 33360 | SUPPL | 2013-04-23 |
| 13919 | SUPPL | 2010-01-06 |
| 33359 | SUPPL | 2010-01-04 |
| 23537 | ORIG | 2008-01-07 |
| 20091 | SUPPL | 2007-07-06 |
| 13918 | SUPPL | 2006-01-20 |
| 11074 | SUPPL | 2006-01-10 |
| 33358 | SUPPL | 2004-04-05 |
| 719 | SUPPL | 2004-02-27 |
| 13917 | SUPPL | 2002-03-15 |