Application 021627
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAMENDA | MEMANTINE HYDROCHLORIDE | SOLUTION;ORAL | 2MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021627-001 | NAMENDA | MEMANTINE HYDROCHLORIDE | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 |
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| 2026-08 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021627-001 | NAMENDA | 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / ORAL | RLD | 2005-04-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021627-001 | NAMENDA | 2MG/ML | SOLUTION / ORAL | RLD | 2005-04-18 | f41ea6bd6efb… |
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 Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | bf395152-2885-4633-bf3f-2da46e7b79f1 | 2023-03-30 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 8bd5b908-f46a-4ced-9408-45984d716149 | 2023-03-24 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0 | 2023-03-03 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 54a12ddf-306b-4eb7-a7c3-c7b58df3b372 | 2023-03-03 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | fac8c59b-5bf5-478e-8223-a5ecaa400625 | 2023-03-03 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | c8f96b24-de66-4a17-b798-42b42a25e84c | 2023-03-03 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 42f0a9f2-4aa4-46fb-bc24-d3df843bb906 | 2023-02-09 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | b86c0f6e-480b-40e7-aa4d-21bd0659101d | 2023-01-30 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 989fa756-7d70-4ea7-bb5e-f4395e48589d | 2022-12-31 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ceb733fa-4526-4b76-ab6a-bd4c5638afff | 2022-11-08 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | 2b2dcd54-47e0-494b-85d2-c28c3adbe737 | 2022-11-05 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 910827aa-5320-446c-8f66-3f17c0ee36d9 | 2022-10-11 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Viona Pharmaceuticals Inc | dcbdb62a-a4e2-4058-b73c-46005f2a5d51 | 2022-10-08 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | af2b73da-1be4-4b7f-929b-acb3b9a10f78 | 2021-10-11 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90 | 2020-12-07 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Dr. Reddys Laboratories Limited | a71e2482-5266-d03e-8b36-862afe78c9a4 | 2019-02-08 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Actavis Pharma, Inc. | 72973b46-f307-4a9e-8fb1-ad2cbccfd736 | 2018-11-01 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | c8f5c20b-4573-44c5-89fc-4da11b2e1fe1 | 2017-11-30 | Warnings, Adverse reactions | MEMANTINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.