Application 215383
- Type
- NDA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WELIREG | BELZUTIFAN | TABLET;ORAL | 40MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215383-001 | WELIREG | BELZUTIFAN | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 |
| N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 |
| N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 |
| N215383-001 | 9908845 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2021-09-09 |
| N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 |
| N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 |
| N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 |
| N215383-001 | RE49948 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2024-05-28 |
| N215383-001 | 10335388 | 2036-04-14 | U-4565 | 2026-07-08 | |
| N215383-001 | 12358870 | 2042-06-30 | Drug product | 2025-07-24 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215383-001 | NCE | 2026-08-13 |
| N215383-001 | I-931 | 2026-12-14 |
| N215383-001 | I-968 | 2028-05-14 |
| N215383-001 | ODE-364 | 2028-08-13 |
| N215383-001 | I-994 | 2029-06-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215383-001 | WELIREG | 40MG | TABLET / ORAL | RLD, RS | 2021-08-13 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 9908845 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2021-09-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | RE49948 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2024-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 10335388 | 2036-04-14 | U-4565 | 2026-07-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215383-001 | 12358870 | 2042-06-30 | Drug product | 2025-07-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 9908845 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2021-09-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | RE49948 | 2034-09-05 | U-4565 | Drug substance, Drug product | 2024-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 10335388 | 2036-04-14 | U-4565 | 2026-07-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215383-001 | 12358870 | 2042-06-30 | Drug product | 2025-07-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215383-001 | 12358870 | 2042-06-30 | Drug product | 2025-07-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215383-001 | 12358870 | 2042-06-30 | Drug product | 2025-07-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | 9908845 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2021-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | 9908845 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2021-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | 9908845 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2021-09-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | RE49948 | 2034-09-05 | U-4195 | Drug substance, Drug product | 2024-05-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | RE49948 | 2034-09-05 | U-4176 | Drug substance, Drug product | 2024-05-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215383-001 | RE49948 | 2034-09-05 | U-3201 | Drug substance, Drug product | 2024-05-28 | 6a471c1ec25d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-10-29 15:01 UTC | 2024-10 | N215383-001 | NCE | 2026-08-13 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215383-001 | I-931 | 2026-12-14 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215383-001 | ODE-364 | 2028-08-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215383-001 | NCE | 2026-08-13 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215383-001 | I-931 | 2026-12-14 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215383-001 | ODE-364 | 2028-08-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215383-001 | NCE | 2026-08-13 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215383-001 | I-931 | 2026-12-14 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215383-001 | ODE-364 | 2028-08-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215383-001 | NCE | 2026-08-13 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215383-001 | I-931 | 2026-12-14 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215383-001 | ODE-364 | 2028-08-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N215383-001 | NCE | 2026-08-13 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N215383-001 | I-931 | 2026-12-14 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N215383-001 | ODE-364 | 2028-08-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215383-001 | NCE | 2026-08-13 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215383-001 | ODE-364 | 2028-08-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N215383-001 | NCE | 2026-08-13 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N215383-001 | ODE-364 | 2028-08-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N215383-001 | NCE | 2026-08-13 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N215383-001 | ODE-364 | 2028-08-13 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N215383-001 | NCE | 2026-08-13 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N215383-001 | ODE-364 | 2028-08-13 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N215383-001 | NCE | 2026-08-13 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N215383-001 | ODE-364 | 2028-08-13 | 782e0a99824c… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215383-001 | NCE | 2026-08-13 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215383-001 | I-931 | 2026-12-14 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215383-001 | ODE-364 | 2028-08-13 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N215383-001 | NCE | 2026-08-13 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N215383-001 | ODE-364 | 2028-08-13 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N215383-001 | NCE | 2026-08-13 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N215383-001 | ODE-364 | 2028-08-13 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215383-001 | NCE | 2026-08-13 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215383-001 | ODE-364 | 2028-08-13 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215383-001 | NCE | 2026-08-13 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215383-001 | ODE-364 | 2028-08-13 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215383-001 | NCE | 2026-08-13 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215383-001 | ODE-364 | 2028-08-13 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215383-001 | NCE | 2026-08-13 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215383-001 | ODE-364 | 2028-08-13 | 3f0d92c62455… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85859 | SUPPL | 2026-05-11 |
| 82302 | SUPPL | 2025-05-23 |
| 82243 | SUPPL | 2025-05-14 |
| 82242 | SUPPL | 2025-05-14 |
| 81961 | SUPPL | 2025-04-24 |
| 81960 | SUPPL | 2025-04-24 |
| 81932 | SUPPL | 2025-04-21 |
| 81931 | SUPPL | 2025-04-21 |
| 77633 | SUPPL | 2024-03-12 |
| 77630 | SUPPL | 2024-03-12 |
| 76857 | SUPPL | 2023-12-15 |
| 76841 | SUPPL | 2023-12-15 |
| 76840 | SUPPL | 2023-12-15 |
| 68566 | ORIG | 2021-09-10 |
| 68375 | ORIG | 2021-08-16 |
| 68366 | ORIG | 2021-08-13 |
| 68363 | ORIG | 2021-08-13 |