Application 021627

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAMENDA	MEMANTINE HYDROCHLORIDE	SOLUTION;ORAL	2MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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N021627-001	NAMENDA	MEMANTINE HYDROCHLORIDE	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2005-04-18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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`84e616aacf4f…`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N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`caaa826d4ba7…`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UTC	2026-02	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`011fe1cb6892…`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of this ZIP	2025-12	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`31067a03dcf5…`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UTC	2025-08	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`6a471c1ec25d…`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.

Matched openFDA labels page 1 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	007d4cb9-3fa9-40f3-b5ca-4083eccd6038	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	REMEDYREPACK INC.	cbfd9d95-f50b-45ff-9857-9f1712c45e56	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	becb09dc-174d-4817-88d4-f38c8adcd309	2026-06-17	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	d0a5e0fc-04e3-417d-bef3-9b309ff71597	2026-06-09	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	e5754973-e73b-4a25-abb4-80f91880f018	2026-06-05	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	afc07196-be28-4521-afc0-d4aa5b6fd46d	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	a74050c4-5a37-4fa1-85d9-85831525cfeb	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	d0839a2d-35f1-1f14-e053-2995a90ad549	2026-03-06	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	d1f97615-e888-421e-b50a-95a87a1965ff	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Chartwell RX, LLC	a7b76864-6de7-45f6-be5b-5ecfca811627	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	65c9e7bc-71f0-4113-8de1-4fcaa591735f	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	24290655-47f3-4042-a977-a832c5161d2c	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	47e4a696-fe2a-c905-e063-6294a90a7415	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	AvPAK	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	f6ce7cca-d245-44f2-986c-2a8d85dbb5fb	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	1b4a0162-9cb4-4ba6-8c02-95c2955734ae	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	6e0ade9e-b721-4701-bcb7-de464e19e707	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	292671f2-f221-4a3d-a110-a266a9527e04	2025-11-27	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	62e32b0b-1eb2-424d-bfd2-d27ef27d35f3	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Carlsbad Technology, Inc.	30b4d5c4-0a31-c385-e063-6394a90adbce	2025-06-23	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
28263	SUPPL	2014-08-12
15886	SUPPL	2014-08-12
37351	SUPPL	2013-10-25
28262	SUPPL	2013-10-25
42238	ORIG	2006-10-18
28261	SUPPL	2006-10-13
5876	SUPPL	2006-04-21
37350	ORIG	2005-04-19
5875	ORIG	2005-04-19