Application 079225

Type: ANDA
Sponsor: MYLAN

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 43.

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
A079225-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2015-01-30
A079225-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2015-01-30

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079225-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	2015-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079225-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	2015-01-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A079225-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079225-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079225-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079225-002	AB	1	`ea99ee380514…`

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 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	62e32b0b-1eb2-424d-bfd2-d27ef27d35f3	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Carlsbad Technology, Inc.	30b4d5c4-0a31-c385-e063-6394a90adbce	2025-06-23	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3662b11a-354a-b683-e063-6394a90a0086	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE	Rising Pharma Holdings, Inc.	a282fbed-8304-458e-a0e9-5eaccc95339b	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	f2b7538d-8ca1-4ac7-a172-d268e2fa9a52	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride 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 brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Coupler LLC	2d54be77-75b2-76b3-e063-6294a90a0cc0	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	ec825bef-2313-45c2-8858-b43197680155	2024-11-30		Name fallback brand name: Memantine hydrochloride 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 brand name: memantine hydrochloride 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 brand name: memantine hydrochloride 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 brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	514421f3-f525-43e8-aecc-8b2bbffd00dc	2024-08-16		Name fallback brand name: Memantine Hydrochloride 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 brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Vitruvias Therapeutics, Inc.	0c7fd6ab-2ce5-4110-b6e6-9103c8da0765	2024-02-16	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	0ad2246a-ffa0-43a0-8094-58279d3e3a74	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	be919d34-e9f4-49c8-8145-2dcafb7cb88c	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride 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 brand name: Memantine Hydrochloride 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 brand name: Memantine Hydrochloride 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 brand name: Memantine hydrochloride 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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1103	Memantine Hydrochloride	memantine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1103	Memantine Hydrochloride	memantine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1104	Memantine Hydrochloride	memantine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1104	Memantine Hydrochloride	memantine	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-005	Memantine Hydrochloride	memantine	Mylan Institutional Inc.	ANDA	Current
42292-006	Memantine Hydrochloride	memantine	Mylan Institutional Inc.	ANDA	Current
63629-7090	Memantine Hydrochloride	memantine	Bryant Ranch Prepack	ANDA	Current
63629-7090	Memantine Hydrochloride	memantine	Bryant Ranch Prepack	ANDA	Current