Application 022580
- Type
- NDA
- Sponsor
- VIVUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 3.75MG BASE;23MG | Yes | No |
| 002 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE;46MG | Yes | No |
| 003 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 11.25MG BASE;69MG | Yes | No |
| 004 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | CAPSULE, EXTENDED RELEASE;ORAL | EQ 15MG BASE;92MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022580-001 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-002 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-003 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 |
| N022580-004 | QSYMIA | PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022580-001 | AB |
| N022580-002 | AB |
| N022580-003 | AB |
| N022580-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | |
| N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | |
| N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-002 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-002 | 8580299 | 2029-06-14 | U-3399 | ||
| N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-003 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-003 | 8580299 | 2029-06-14 | U-3399 | ||
| N022580-004 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | |
| N022580-004 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | |
| N022580-004 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | |
| N022580-004 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | |
| N022580-004 | 8580298 | 2029-05-15 | Drug product | ||
| N022580-004 | 8580299 | 2029-06-14 | U-3399 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N022580-001 | M-308 | 2027-09-13 |
| N022580-002 | M-308 | 2027-09-13 |
| N022580-003 | M-308 | 2027-09-13 |
| N022580-004 | M-308 | 2027-09-13 |
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 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-001 | QSYMIA | EQ 3.75MG BASE;23MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-002 | QSYMIA | EQ 7.5MG BASE;46MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-003 | QSYMIA | EQ 11.25MG BASE;69MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2012-07-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-004 | QSYMIA | EQ 15MG BASE;92MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2012-07-17 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022580-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022580-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022580-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022580-004 | AB | 1 | d06236e962d9… |
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 | N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 8580298 | 2029-05-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | 8580299 | 2029-06-14 | U-3399 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 8580298 | 2029-05-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | 8580299 | 2029-06-14 | U-3399 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 8580298 | 2029-05-15 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | 8580299 | 2029-06-14 | U-3399 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 8580298 | 2029-05-15 | Drug product | 2013-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | 8580299 | 2029-06-14 | U-3399 | 2013-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 8580298 | 2029-05-15 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | 8580299 | 2029-06-14 | U-3399 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | 8895057 | 2028-06-09 | U-3398 | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | 8895058 | 2028-06-09 | Drug product | 2014-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | 9011905 | 2028-06-09 | Drug product | 2015-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | 9011906 | 2028-06-09 | U-3398 | 2015-05-13 | 31067a03dcf5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022580-001 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-002 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-003 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022580-004 | M-308 | 2027-09-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-001 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-002 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-003 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | NPP | 2025-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022580-004 | M-308 | 2027-09-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-001 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-002 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-003 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | NPP | 2025-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022580-004 | M-308 | 2027-09-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-001 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-002 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-003 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | NPP | 2025-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022580-004 | M-308 | 2027-09-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-001 | M-308 | 2027-09-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-002 | M-308 | 2027-09-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-003 | M-308 | 2027-09-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | NPP | 2025-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022580-004 | M-308 | 2027-09-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | NPP | 2025-06-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-001 | M-308 | 2027-09-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | NPP | 2025-06-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022580-002 | M-308 | 2027-09-13 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| phentermine and topiramate | PHENTERMINE AND TOPIRAMATE | Prasco Laboratories | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 2026-05-18 | Warnings, Adverse reactions | 022580 NDA022580 |
| Qsymia | PHENTERMINE AND TOPIRAMATE | Vivus LLC | 40dd5602-53da-45ac-bb4b-15789aba40f9 | 2026-04-22 | Warnings, Adverse reactions | 022580 NDA022580 62541-203 62541-201 62541-204 62541-202 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62541-201 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-201 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-202 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-203 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus, Inc. | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
| 62541-204 | Qsymia | phentermine and topiramate | Vivus LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85330 | SUPPL | 2026-03-12 |
| 85296 | SUPPL | 2026-03-09 |
| 85352 | SUPPL | 2026-03-06 |
| 82873 | SUPPL | 2025-07-15 |
| 82830 | SUPPL | 2025-07-14 |
| 80255 | SUPPL | 2024-11-21 |
| 80252 | SUPPL | 2024-11-20 |
| 79632 | SUPPL | 2024-09-16 |
| 79598 | SUPPL | 2024-09-16 |
| 77413 | SUPPL | 2024-02-07 |
| 74662 | SUPPL | 2023-06-29 |
| 74657 | SUPPL | 2023-06-29 |
| 74203 | SUPPL | 2023-05-10 |
| 71491 | SUPPL | 2022-06-30 |
| 71455 | SUPPL | 2022-06-27 |
| 71454 | SUPPL | 2022-06-27 |
| 71453 | SUPPL | 2022-06-27 |
| 70441 | SUPPL | 2022-03-09 |
| 66962 | SUPPL | 2021-04-01 |
| 66945 | SUPPL | 2021-04-01 |
| 64961 | SUPPL | 2020-10-21 |
| 64957 | SUPPL | 2020-10-21 |
| 64956 | SUPPL | 2020-10-21 |
| 53506 | SUPPL | 2018-03-29 |
| 53464 | SUPPL | 2018-03-27 |
| 53463 | SUPPL | 2018-03-27 |
| 38864 | SUPPL | 2014-09-30 |
| 29887 | SUPPL | 2014-09-30 |
| 29886 | SUPPL | 2014-09-30 |
| 17744 | SUPPL | 2014-09-30 |
| 17743 | SUPPL | 2014-09-30 |
| 7568 | SUPPL | 2014-09-30 |
| 29885 | SUPPL | 2013-04-18 |
| 17742 | SUPPL | 2013-04-17 |
| 24345 | ORIG | 2013-04-08 |
| 22066 | ORIG | 2013-04-08 |
| 38863 | SUPPL | 2013-03-26 |
| 7567 | SUPPL | 2012-11-06 |
| 17741 | SUPPL | 2012-11-02 |
| 38862 | ORIG | 2012-07-18 |
| 29884 | ORIG | 2012-07-18 |
| 24037 | ORIG | 2012-07-18 |