Application 202344
- Type
- NDA
- Sponsor
- ASCEND THERAPS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BINOSTO | ALENDRONATE SODIUM | TABLET, EFFERVESCENT;ORAL | EQ 70MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0178-0101 | Binosto | alendronate sodium | Mission Pharmacal Company | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics U.S., LLC | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics | NDA | Current |
| 17139-400 | Binosto | alendronate sodium | ASCEND Therapeutics U.S., LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84932 | SUPPL | 2026-02-05 |
| 84920 | SUPPL | 2026-02-05 |
| 84933 | SUPPL | 2026-02-03 |
| 64922 | SUPPL | 2020-10-15 |
| 64919 | SUPPL | 2020-10-14 |
| 63464 | SUPPL | 2020-06-09 |
| 63463 | SUPPL | 2020-06-09 |
| 56235 | SUPPL | 2018-11-01 |
| 46650 | SUPPL | 2017-01-03 |
| 46634 | SUPPL | 2017-01-03 |
| 32247 | SUPPL | 2016-03-24 |
| 32246 | SUPPL | 2015-04-13 |
| 19334 | SUPPL | 2015-04-10 |
| 19333 | SUPPL | 2015-03-03 |
| 32245 | SUPPL | 2015-02-27 |
| 19332 | SUPPL | 2013-08-09 |
| 44854 | ORIG | 2013-04-29 |
| 43398 | ORIG | 2013-04-29 |
| 40173 | SUPPL | 2013-04-23 |
| 10034 | SUPPL | 2013-04-23 |
| 24102 | ORIG | 2012-08-30 |
| 19331 | ORIG | 2012-08-30 |
| 32244 | ORIG | 2012-03-26 |