Application 021164
- Type
- NDA
- Sponsor
- FABRE KRAMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 18.2MG BASE | Yes | Yes |
| 002 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 36.3MG BASE | Yes | No |
| 003 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 54.5MG BASE | Yes | No |
| 004 | EXXUA | GEPIRONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 72.6MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021164-001 | EXXUA | GEPIRONE HYDROCHLORIDE | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | |
| N021164-002 | EXXUA | GEPIRONE HYDROCHLORIDE | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | |
| N021164-003 | EXXUA | GEPIRONE HYDROCHLORIDE | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | |
| N021164-004 | EXXUA | GEPIRONE HYDROCHLORIDE | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021164-001 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | |
| N021164-002 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | |
| N021164-003 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | |
| N021164-004 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N021164-001 | NCE | 2028-09-22 |
| N021164-002 | NCE | 2028-09-22 |
| N021164-003 | NCE | 2028-09-22 |
| N021164-004 | NCE | 2028-09-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2023-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-001 | EXXUA | EQ 18.2MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-002 | EXXUA | EQ 36.3MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-003 | EXXUA | EQ 54.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-004 | EXXUA | EQ 72.6MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2023-09-22 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021164-001 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-002 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-003 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021164-004 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-001 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-002 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-003 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-004 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-001 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-002 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-003 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-004 | 7538116 | 2030-09-02 | U-3699 | 2023-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-001 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-002 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-003 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-004 | 7538116 | 2025-09-02 | U-3699 | 2023-10-18 | d8e5a09893c0… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021164-001 | NCE | 2028-09-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021164-002 | NCE | 2028-09-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021164-003 | NCE | 2028-09-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021164-004 | NCE | 2028-09-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-001 | NCE | 2028-09-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-002 | NCE | 2028-09-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-003 | NCE | 2028-09-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021164-004 | NCE | 2028-09-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-001 | NCE | 2028-09-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-002 | NCE | 2028-09-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-003 | NCE | 2028-09-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021164-004 | NCE | 2028-09-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-001 | NCE | 2028-09-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-002 | NCE | 2028-09-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-003 | NCE | 2028-09-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021164-004 | NCE | 2028-09-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-001 | NCE | 2028-09-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-002 | NCE | 2028-09-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-003 | NCE | 2028-09-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021164-004 | NCE | 2028-09-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-001 | NCE | 2028-09-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-002 | NCE | 2028-09-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-003 | NCE | 2028-09-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021164-004 | NCE | 2028-09-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-001 | NCE | 2028-09-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-002 | NCE | 2028-09-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-003 | NCE | 2028-09-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021164-004 | NCE | 2028-09-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-001 | NCE | 2028-09-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-002 | NCE | 2028-09-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-003 | NCE | 2028-09-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021164-004 | NCE | 2028-09-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-001 | NCE | 2028-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-002 | NCE | 2028-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-003 | NCE | 2028-09-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021164-004 | NCE | 2028-09-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-001 | NCE | 2028-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-002 | NCE | 2028-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-003 | NCE | 2028-09-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021164-004 | NCE | 2028-09-22 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| EXXUA | GEPIRONE | Aytu Therapeutics, LLC | 0c78edd8-6acb-433c-9d34-2527da8d64e1 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 021164 NDA021164 |