Application 022525

Type: NDA
Sponsor: FOREST LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAMENDA XR	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7MG	Yes	No
002	NAMENDA XR	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	14MG	Yes	No
003	NAMENDA XR	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	21MG	Yes	No
004	NAMENDA XR	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	28MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022525-001	NAMENDA XR	MEMANTINE HYDROCHLORIDE	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-002	NAMENDA XR	MEMANTINE HYDROCHLORIDE	14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-003	NAMENDA XR	MEMANTINE HYDROCHLORIDE	21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-004	NAMENDA XR	MEMANTINE HYDROCHLORIDE	28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022525-001	8039009	2029-03-24	U-539		2011-11-16
N022525-001	8039009*PED	2029-09-24		Pediatric extension
N022525-002	8039009	2029-03-24	U-539
N022525-002	8039009*PED	2029-09-24		Pediatric extension
N022525-003	8039009	2029-03-24	U-539
N022525-003	8039009*PED	2029-09-24		Pediatric extension
N022525-004	8039009	2029-03-24	U-539
N022525-004	8039009*PED	2029-09-24		Pediatric extension

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 5 · 172 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	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-002	NAMENDA XR	14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-003	NAMENDA XR	21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-004	NAMENDA XR	28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-002	NAMENDA XR	14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-003	NAMENDA XR	21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-004	NAMENDA XR	28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022525-001	NAMENDA XR	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022525-002	NAMENDA XR	14MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022525-003	NAMENDA XR	21MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022525-004	NAMENDA XR	28MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022525-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022525-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022525-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022525-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022525-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022525-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022525-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022525-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022525-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022525-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022525-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022525-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022525-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022525-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022525-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022525-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022525-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022525-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022525-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022525-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022525-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022525-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022525-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022525-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022525-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022525-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022525-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022525-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022525-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022525-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022525-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022525-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022525-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022525-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022525-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022525-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022525-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022525-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022525-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022525-003	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 680 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022525-001	8039009	2029-03-24	U-539		2011-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-001	8039009*PED	2029-09-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-002	8039009	2029-03-24	U-539			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-002	8039009*PED	2029-09-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-003	8039009	2029-03-24	U-539			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-003	8039009*PED	2029-09-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-004	8039009	2029-03-24	U-539			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022525-004	8039009*PED	2029-09-24		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022525-001	8039009	2029-03-24	U-539		2011-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-001	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-002	8039009	2029-03-24	U-539			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-002	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-003	8039009	2029-03-24	U-539			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-003	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-004	8039009	2029-03-24	U-539			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022525-004	8039009*PED	2029-09-24		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022525-001	8039009	2029-03-24	U-539		2011-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-001	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-002	8039009	2029-03-24	U-539			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-002	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-003	8039009	2029-03-24	U-539			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-003	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-004	8039009	2029-03-24	U-539			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022525-004	8039009*PED	2029-09-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-001	8039009	2029-03-24	U-539		2011-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-001	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-002	8039009	2029-03-24	U-539			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-002	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-003	8039009	2029-03-24	U-539			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-003	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-004	8039009	2029-03-24	U-539			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022525-004	8039009*PED	2029-09-24		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022525-001	8039009	2029-03-24	U-539		2011-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-001	8039009*PED	2029-09-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-002	8039009	2029-03-24	U-539			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-002	8039009*PED	2029-09-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-003	8039009	2029-03-24	U-539			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-003	8039009*PED	2029-09-24		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-004	8039009	2029-03-24	U-539			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022525-004	8039009*PED	2029-09-24		Pediatric extension		`6a471c1ec25d…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-3400	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3400	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3407	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3407	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3407	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3407	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3414	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3414	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3414	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3414	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3421	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3421	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3421	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3421	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3428	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3428	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3428	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3428	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
60505-6208	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6208	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6208	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6209	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6209	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6209	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6210	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6210	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6210	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6211	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6211	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
60505-6211	Memantine Hydrochloride	memantine hydrochloride	Apotex Corp	NDA	Current
68151-5755	Namenda	memantine hydrochloride	Carilion Materials Management	NDA	Current
68151-5817	Namenda	memantine hydrochloride	Carilion Materials Management	NDA	Current
68151-5829	Namenda XR	memantine hydrochloride	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61095	SUPPL	2019-11-29
61053	SUPPL	2019-11-26
7499	SUPPL	2014-10-01
38812	SUPPL	2014-09-30
38811	SUPPL	2014-07-09
29830	SUPPL	2014-07-07
24332	ORIG	2010-12-23
22045	ORIG	2010-12-23
29829	ORIG	2010-06-24
17680	ORIG	2010-06-02
58108	ORIG	1900-01-01
51327	ORIG	1900-01-01
51326	ORIG	1900-01-01
51325	ORIG	1900-01-01