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N021627-001	NAMENDA	MEMANTINE HYDROCHLORIDE	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2005-04-18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N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`84e616aacf4f…`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N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`caaa826d4ba7…`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UTC	2026-02	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`011fe1cb6892…`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of this ZIP	2025-12	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`31067a03dcf5…`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UTC	2025-08	N021627-001	NAMENDA	2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2005-04-18	`6a471c1ec25d…`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 2 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	Aphena Pharma Solutions - Tennessee, LLC	3662b11a-354a-b683-e063-6394a90a0086	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	f2b7538d-8ca1-4ac7-a172-d268e2fa9a52	2025-04-29	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b8b982-db74-7cf4-e063-6394a90a3a6b	2025-03-19	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Coupler LLC	2d54be77-75b2-76b3-e063-6294a90a0cc0	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	ec825bef-2313-45c2-8858-b43197680155	2024-11-30		Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	4d48c958-b606-4427-8502-53450718eefb	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	ca619439-f4ca-43f1-9261-9aa2b6dc7450	2024-09-05	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	514421f3-f525-43e8-aecc-8b2bbffd00dc	2024-08-16		Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	2024-05-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Vitruvias Therapeutics, Inc.	0c7fd6ab-2ce5-4110-b6e6-9103c8da0765	2024-02-16	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	0ad2246a-ffa0-43a0-8094-58279d3e3a74	2024-02-06	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	be919d34-e9f4-49c8-8145-2dcafb7cb88c	2024-02-06	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	66db6d61-cf1d-46ca-a645-19e9a20f4617	2023-11-24	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	2fdf0b2b-0337-472d-83ec-075c17c9b0d0	2023-11-22	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	eac265e6-6ea4-4368-acff-2efe6a8dd40a	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d1963395-3cf7-4433-bf2c-06295bb1c5b0	2023-10-05	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	2023-10-04	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	d1c2ec99-7183-46e3-a96e-4f23e20b8b06	2023-04-19	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