Application 200891

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

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

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
A200891-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-10-13
A200891-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A200891-001	AB
A200891-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200891-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200891-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200891-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200891-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200891-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200891-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200891-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200891-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200891-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200891-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200891-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200891-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200891-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200891-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200891-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200891-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200891-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200891-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200891-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200891-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200891-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200891-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200891-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200891-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200891-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200891-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200891-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200891-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200891-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200891-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200891-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	b86c0f6e-480b-40e7-aa4d-21bd0659101d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200891 application number: ANDA200891 ndc (product): 46708-452 ndc (product): 46708-451
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	af2b73da-1be4-4b7f-929b-acb3b9a10f78	2021-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200891 application number: ANDA200891 ndc (product): 62332-076 ndc (product): 62332-075

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-165	Memantine Hydrochloride	memantine hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
46708-451	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-451	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-452	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-452	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-075	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-075	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-075	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-076	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-076	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-076	Memantine Hydrochloride	memantine hydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current