Application 206439
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;14MG | Yes | No |
| 002 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;28MG | Yes | Yes |
| 003 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;7MG | Yes | No |
| 004 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;21MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N206439-001 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 |
| N206439-002 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 |
| N206439-003 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 |
| N206439-004 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N206439-001 | AB |
| N206439-002 | AB |
| N206439-003 | AB |
| N206439-004 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N206439-001 | 8039009 | 2029-03-24 | U-1641 | ||
| N206439-001 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N206439-001 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | |
| N206439-002 | 8039009 | 2029-03-24 | U-1641 | 2015-01-22 | |
| N206439-002 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N206439-002 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | |
| N206439-003 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | |
| N206439-003 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N206439-003 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 | |
| N206439-004 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | |
| N206439-004 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N206439-004 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 |
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 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2014-12-23 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2014-12-23 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2014-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2014-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2014-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N206439-001 | NAMZARIC | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2014-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N206439-002 | NAMZARIC | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2014-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N206439-003 | NAMZARIC | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2016-07-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N206439-004 | NAMZARIC | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2016-07-18 | 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 | N206439-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N206439-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N206439-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N206439-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N206439-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N206439-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N206439-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N206439-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N206439-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N206439-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N206439-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N206439-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N206439-004 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N206439-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N206439-004 | AB | 1 | 1c564ffb4f44… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206439-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206439-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206439-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N206439-004 | AB | 1 | a50c72e98297… |
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 | N206439-001 | 8039009 | 2029-03-24 | U-1641 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N206439-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N206439-001 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-002 | 8039009 | 2029-03-24 | U-1641 | 2015-01-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N206439-002 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-003 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N206439-003 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-004 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N206439-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N206439-004 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8293794 | 2025-11-22 | Drug product | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8338485 | 2025-11-22 | Drug product | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8338486 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8580858 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8039009 | 2029-03-24 | U-1641 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-001 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8293794 | 2025-11-22 | Drug product | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8338485 | 2025-11-22 | Drug product | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8338486 | 2025-11-22 | U-1641 | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8580858 | 2025-11-22 | U-1641 | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8039009 | 2029-03-24 | U-1641 | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-002 | 8058291 | 2029-12-05 | U-1641 | 2015-01-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8293794 | 2025-11-22 | Drug product | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8338485 | 2025-11-22 | Drug product | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8338486 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8580858 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-003 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8293794 | 2025-11-22 | Drug product | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8338485 | 2025-11-22 | Drug product | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8338486 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8580858 | 2025-11-22 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8039009 | 2029-03-24 | U-1641 | 2016-08-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N206439-004 | 8058291 | 2029-12-05 | U-1641 | 2016-08-16 | 31067a03dcf5… |
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 |
|---|---|---|---|---|---|---|
| Namzaric | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | Allergan, Inc. | 90fedc32-19e5-480c-afc6-f35a5cf4b9aa | 2026-03-06 | Warnings, Adverse reactions | 206439 NDA206439 0456-1207 0456-1228 0456-1214 0456-1221 0456-1229 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0456-1207 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1207 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1207 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1214 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1214 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1214 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1221 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1221 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1221 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1228 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1228 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1228 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1229 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1229 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-1229 | Namzaric | memantine hydrochloride and donepezil hydrochloride | Allergan, Inc. | NDA | Current |