Application 021455
- Type
- NDA
- Sponsor
- HOFFMANN LA ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BONIVA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | BONIVA | IBANDRONATE SODIUM | TABLET;ORAL | EQ 150MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-0186 | Boniva | ibandronate sodium | Genentech, Inc. | NDA | Current |
| 0004-0186 | Boniva | ibandronate sodium | Genentech, Inc. | NDA | Current |
| 0004-0186 | Boniva | ibandronate sodium | Genentech, Inc. | NDA | Current |
| 0004-0186 | Boniva | ibandronate sodium | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46098 | SUPPL | 2016-12-08 |
| 46097 | SUPPL | 2016-12-08 |
| 46095 | SUPPL | 2016-12-07 |
| 5441 | SUPPL | 2015-04-13 |
| 36983 | SUPPL | 2015-04-10 |
| 15523 | SUPPL | 2015-03-24 |
| 27846 | SUPPL | 2015-03-19 |
| 42177 | SUPPL | 2015-03-11 |
| 36982 | SUPPL | 2014-12-19 |
| 27845 | SUPPL | 2014-12-18 |
| 27844 | SUPPL | 2013-04-24 |
| 5440 | SUPPL | 2013-04-24 |
| 36981 | SUPPL | 2013-04-23 |
| 15522 | SUPPL | 2013-04-23 |
| 27843 | SUPPL | 2011-07-06 |
| 27842 | SUPPL | 2011-02-02 |
| 15521 | SUPPL | 2011-01-31 |
| 5439 | SUPPL | 2010-01-15 |
| 15520 | SUPPL | 2010-01-08 |
| 27841 | SUPPL | 2008-11-28 |
| 27840 | SUPPL | 2007-02-23 |
| 15519 | SUPPL | 2007-02-21 |
| 5438 | SUPPL | 2006-06-20 |
| 5437 | SUPPL | 2005-03-28 |
| 23072 | SUPPL | 2005-03-25 |
| 15518 | SUPPL | 2005-03-25 |
| 44125 | ORIG | 2003-12-09 |
| 42176 | ORIG | 2003-07-02 |
| 5436 | ORIG | 2003-06-08 |
| 15517 | ORIG | 2003-05-29 |