Application 208328
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;14MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;28MG | No | No |
| 003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;7MG | No | No |
| 004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG;21MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | |
| A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | |
| A208328-003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | |
| A208328-004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208328-001 | AB |
| A208328-002 | AB |
| A208328-003 | AB |
| A208328-004 | AB |
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 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-003 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-004 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2025-02-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2017-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208328-001 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208328-002 | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | 10MG;28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2017-01-27 | 5d02ea3f76ae… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208328-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208328-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208328-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208328-002 | AB | 1 | 03ed91905a0d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208328-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208328-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208328-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208328-004 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-001 | PC | 2025-07-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208328-002 | PC | 2025-07-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-001 | PC | 2025-07-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208328-002 | PC | 2025-07-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-001 | PC | 2025-07-15 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208328-002 | PC | 2025-07-15 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-001 | PC | 2025-07-15 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208328-002 | PC | 2025-07-15 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| Memantine and Donepezil Hydrochlorides Extended-release | MEMANTINE AND DONEPEZIL | AvKARE | 2d821427-34ca-3c5d-e063-6394a90a9013 | 2025-02-06 | Warnings, Adverse reactions | 208328 ANDA208328 |
| Memantine and Donepezil Hydrochlorides Extended-release | MEMANTINE AND DONEPEZIL | Amneal Pharmaceuticals NY LLC | 2335950c-be3b-4248-ad04-e9763aee47d2 | 2024-12-17 | Warnings, Adverse reactions | 208328 ANDA208328 69238-1248 69238-1247 69238-1553 69238-1552 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69238-1247 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1247 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1247 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1247 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1247 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1248 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1248 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1248 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1248 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1248 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1552 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1552 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1552 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1552 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1553 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1553 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1553 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1553 | Memantine and Donepezil Hydrochlorides Extended-release | Memantine and Donepezil | Amneal Pharmaceuticals NY LLC | ANDA | Current |