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N022525-001	NAMENDA XR	MEMANTINE HYDROCHLORIDE	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-002	NAMENDA XR	MEMANTINE HYDROCHLORIDE	14MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-003	NAMENDA XR	MEMANTINE HYDROCHLORIDE	21MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21
N022525-004	NAMENDA XR	MEMANTINE HYDROCHLORIDE	28MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2010-06-21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 3 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	Bryant Ranch Prepack	bf395152-2885-4633-bf3f-2da46e7b79f1	2023-03-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	8bd5b908-f46a-4ced-9408-45984d716149	2023-03-24	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	54a12ddf-306b-4eb7-a7c3-c7b58df3b372	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	fac8c59b-5bf5-478e-8223-a5ecaa400625	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	c8f96b24-de66-4a17-b798-42b42a25e84c	2023-03-03	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	42f0a9f2-4aa4-46fb-bc24-d3df843bb906	2023-02-09	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	b86c0f6e-480b-40e7-aa4d-21bd0659101d	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	989fa756-7d70-4ea7-bb5e-f4395e48589d	2022-12-31	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aurobindo Pharma Limited	ceb733fa-4526-4b76-ab6a-bd4c5638afff	2022-11-08	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b2dcd54-47e0-494b-85d2-c28c3adbe737	2022-11-05	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	910827aa-5320-446c-8f66-3f17c0ee36d9	2022-10-11	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	2022-10-08	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	af2b73da-1be4-4b7f-929b-acb3b9a10f78	2021-10-11	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90	2020-12-07	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Dr. Reddys Laboratories Limited	a71e2482-5266-d03e-8b36-862afe78c9a4	2019-02-08	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Actavis Pharma, Inc.	72973b46-f307-4a9e-8fb1-ad2cbccfd736	2018-11-01	Warnings, Adverse reactions	Name fallback generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c8f5c20b-4573-44c5-89fc-4da11b2e1fe1	2017-11-30	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