Application 022560
- Type
- NDA
- Sponsor
- APIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATELVIA | RISEDRONATE SODIUM | TABLET, DELAYED RELEASE;ORAL | 35MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0430-0979 | Atelvia | risedronate sodium | Allergan, Inc. | NDA | Current |
| 0430-0979 | Atelvia | risedronate sodium | Allergan, Inc. | NDA | Current |
| 0430-0979 | Atelvia | risedronate sodium | Allergan, Inc. | NDA | Current |
| 0430-0979 | Atelvia | risedronate sodium | Allergan, Inc. | NDA | Current |
| 0430-0979 | Atelvia | risedronate sodium | Allergan, Inc. | NDA | Current |
| 0591-3876 | Risedronate Sodium | risedronate sodium | Actavis Pharma, Inc. | NDA | Current |
| 59762-0407 | Risedronate Sodium | risedronate sodium | Greenstone LLC | NDA | Current |
| 59762-0407 | Risedronate Sodium | risedronate sodium | Greenstone LLC | NDA | Current |
| 59762-0407 | Risedronate Sodium | risedronate sodium | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84934 | SUPPL | 2026-02-05 |
| 84919 | SUPPL | 2026-02-05 |
| 84935 | SUPPL | 2026-02-03 |
| 64299 | SUPPL | 2020-08-19 |
| 64297 | SUPPL | 2020-08-19 |
| 64296 | SUPPL | 2020-08-19 |
| 46101 | SUPPL | 2016-12-08 |
| 7532 | SUPPL | 2015-04-13 |
| 17709 | SUPPL | 2015-04-10 |
| 38838 | SUPPL | 2015-03-27 |
| 29858 | SUPPL | 2015-03-27 |
| 7531 | SUPPL | 2013-04-24 |
| 17708 | SUPPL | 2013-04-23 |
| 38837 | SUPPL | 2012-08-15 |
| 29857 | SUPPL | 2012-08-15 |
| 17707 | SUPPL | 2012-03-22 |
| 17706 | SUPPL | 2012-03-22 |
| 44189 | ORIG | 2011-12-20 |
| 29856 | SUPPL | 2011-08-24 |
| 24340 | ORIG | 2011-03-21 |
| 22056 | ORIG | 2011-03-21 |
| 29855 | SUPPL | 2011-02-15 |
| 7530 | SUPPL | 2011-02-15 |
| 7529 | ORIG | 2010-10-19 |
| 17705 | ORIG | 2010-10-18 |