Application 208173

Type: ANDA
Sponsor: HIKMA PHARMS

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 1.

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
A208173-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2020-02-28
A208173-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2020-02-28

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 · 74 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
2026-02-19 14:30 UTC	2026-02	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2020-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2020-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208173-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-02-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208173-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-02-28	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208173-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208173-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208173-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208173-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208173-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208173-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208173-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208173-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208173-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208173-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208173-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208173-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208173-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208173-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208173-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208173-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208173-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208173-002	AB	1	`c0c555d07b60…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208173-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208173-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208173-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208173-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208173-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208173-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208173-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208173-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208173-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208173-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208173-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208173-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208173-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208173-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208173-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208173-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208173-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208173-002	AB	1	`cb3db0bc1861…`

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d1963395-3cf7-4433-bf2c-06295bb1c5b0	2023-10-05	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	2023-10-04	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE	Amneal Pharmaceuticals of New York LLC	054069b5-7aac-4106-821f-ebf7fd531b4f	2023-08-17	Warnings, Adverse reactions	Name fallback brand name: Memantine hydrochloride
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	d1c2ec99-7183-46e3-a96e-4f23e20b8b06	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	bf395152-2885-4633-bf3f-2da46e7b79f1	2023-03-30	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	8bd5b908-f46a-4ced-9408-45984d716149	2023-03-24	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	54a12ddf-306b-4eb7-a7c3-c7b58df3b372	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	fac8c59b-5bf5-478e-8223-a5ecaa400625	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	c8f96b24-de66-4a17-b798-42b42a25e84c	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	42f0a9f2-4aa4-46fb-bc24-d3df843bb906	2023-02-09	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Limited	b86c0f6e-480b-40e7-aa4d-21bd0659101d	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	989fa756-7d70-4ea7-bb5e-f4395e48589d	2022-12-31	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	POLYGEN PHARMACEUTICALS INC.	c343b0c5-3bfc-4b94-9483-a56924f6dcdb	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aurobindo Pharma Limited	ceb733fa-4526-4b76-ab6a-bd4c5638afff	2022-11-08	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	Aurobindo Pharma Limited	2b2dcd54-47e0-494b-85d2-c28c3adbe737	2022-11-05	Warnings, Adverse reactions	Name fallback brand name: MEMANTINE HYDROCHLORIDE generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	910827aa-5320-446c-8f66-3f17c0ee36d9	2022-10-11	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	2022-10-08	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	af2b73da-1be4-4b7f-929b-acb3b9a10f78	2021-10-11	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride 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 brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE