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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022560-001 | ATELVIA | RISEDRONATE SODIUM | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022560-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | |
| N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 |
| N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022560-001 | ATELVIA | 35MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-10-08 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022560-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022560-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022560-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022560-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022560-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022560-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022560-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022560-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022560-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022560-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022560-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022560-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022560-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022560-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022560-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022560-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022560-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022560-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022560-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022560-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022560-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022560-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022560-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022560-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022560-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022560-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022560-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022560-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022560-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022560-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022560-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022560-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022560-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022560-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022560-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022560-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022560-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022560-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022560-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022560-001 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022560-001 | 7645459 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022560-001 | 7645460 | 2028-01-09 | U-662 | Drug product | 2010-11-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022560-001 | 8246989 | 2026-01-16 | Drug product | 2012-08-28 | 8072bd15b7f6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Atelvia | RISEDRONATE SODIUM | Allergan, Inc. | c8b9ab88-1a26-46c3-80ec-4eaa45202021 | 2026-02-03 | Warnings, Adverse reactions | 022560 NDA022560 0430-0979 |
| Risedronate Sodium | RISEDRONATE SODIUM | Mylan Pharmaceuticals, Inc. | c89430be-15f1-4b8b-ab7e-738de716ee7d | 2026-02-03 | Warnings, Adverse reactions | 022560 NDA022560 59762-0407 |
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 |