Application 021487

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAMENDA	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
002	NAMENDA	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021487-001	NAMENDA	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		RLD	2003-10-16
N021487-002	NAMENDA	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		RLD	2003-10-16

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021487-001	NAMENDA	5MG	TABLET / ORAL		RLD	2003-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021487-002	NAMENDA	10MG	TABLET / ORAL		RLD	2003-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	NAMENDA	5MG	TABLET / ORAL	AB	RLD	2003-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	NAMENDA	10MG	TABLET / ORAL	AB	RLD, RS	2003-10-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021487-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021487-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021487-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021487-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021487-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021487-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021487-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021487-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021487-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021487-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021487-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021487-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021487-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021487-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021487-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021487-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021487-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021487-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021487-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021487-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021487-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021487-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021487-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021487-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021487-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021487-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021487-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021487-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021487-002	AB	1	`782e0a99824c…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	e5754973-e73b-4a25-abb4-80f91880f018	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487 ndc (product): 55154-2666 ndc (product): 55154-2667
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Actavis Pharma, Inc.	72973b46-f307-4a9e-8fb1-ad2cbccfd736	2018-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487 ndc (product): 0591-3870 ndc (product): 0591-3875 ndc (product): 0591-3900
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c8f5c20b-4573-44c5-89fc-4da11b2e1fe1	2017-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021487 application number: NDA021487 ndc (product): 71610-011

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-3200	Namenda	Memantine Hydrochloride	Allergan, Inc.	NDA	Current
0456-3200	Namenda	Memantine Hydrochloride	Allergan, Inc.	NDA	Current
0456-3200	Namenda	Memantine Hydrochloride	Allergan, Inc.	NDA	Current
0456-3200	Namenda	Memantine Hydrochloride	Allergan, Inc.	NDA	Current
0456-3200	Namenda	Memantine Hydrochloride	Allergan, Inc.	NDA	Current
0456-3205	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3205	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3205	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3205	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3205	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3210	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3210	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3210	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3210	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0456-3210	Namenda	memantine hydrochloride	Allergan, Inc.	NDA	Current
0591-3011	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3870	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3875	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
0591-3900	memantine hydrochloride	memantine hydrochloride	Actavis Pharma, Inc.	NDA	Current
21695-169	Namenda	memantine hydrochloride	Rebel Distributors Corp	NDA	Current
21695-232	Namenda	memantine hydrochloride	Rebel Distributors Corp	NDA	Current
55154-2666	memantine hydrochloride	memantine hydrochloride	Cardinal Health 107, LLC	NDA	Current
55154-2666	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2666	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2666	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2666	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2667	memantine hydrochloride	memantine hydrochloride	Cardinal Health 107, LLC	NDA	Current
55154-2667	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2667	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-2667	memantine hydrochloride	memantine hydrochloride	Cardinal Health	NDA	Current
55154-4617	Namenda	Memantine Hydrochloride	Cardinal Health	NDA	Current
55154-4617	Namenda	Memantine Hydrochloride	Cardinal Health	NDA	Current
55154-4618	Namenda	Memantine Hydrochloride	Cardinal Health	NDA	Current
55289-937	Namenda	memantine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-937	Namenda	memantine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-937	Namenda	memantine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-937	Namenda	memantine hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3383	Namenda	memantine hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-3383	Namenda	memantine hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-5291	Namenda	memantine hydrochloride	Bryant Ranch Prepack	NDA	Current
63629-5291	Namenda	memantine hydrochloride	Bryant Ranch Prepack	NDA	Current
67046-489	Namenda	memantine hydrochloride	Contract Pharmacy Services-PA	NDA	Current
71610-011	memantine hydrochloride	memantine hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56434	SUPPL	2018-11-14
56283	SUPPL	2018-11-06
37054	SUPPL	2013-10-25
27916	SUPPL	2013-10-25
15585	SUPPL	2013-10-25
15584	SUPPL	2013-10-25
5522	SUPPL	2013-10-25
5521	SUPPL	2013-10-25
5520	SUPPL	2006-10-13
27915	SUPPL	2006-04-21
5519	SUPPL	2005-05-20
27914	SUPPL	2005-05-03
27913	SUPPL	2004-09-29
42191	ORIG	2003-12-31
27912	ORIG	2003-10-22
15583	ORIG	2003-10-20