Application 206528

Type: ANDA
Sponsor: AJANTA PHARMA 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
A206528-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-11-30
A206528-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206528-001	AB
A206528-002	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	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206528-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206528-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-11-30	`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	A206528-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206528-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206528-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206528-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206528-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206528-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206528-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206528-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206528-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206528-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206528-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206528-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206528-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206528-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206528-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206528-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206528-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206528-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206528-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206528-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206528-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206528-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206528-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206528-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206528-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206528-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206528-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206528-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206528-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	becb09dc-174d-4817-88d4-f38c8adcd309	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	afc07196-be28-4521-afc0-d4aa5b6fd46d	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528 ndc (product): 71335-1899
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	292671f2-f221-4a3d-a110-a266a9527e04	2025-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528 ndc (product): 27241-071 ndc (product): 27241-070
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b8b982-db74-7cf4-e063-6394a90a3a6b	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine HCL	MEMANTINE HCL	Direct_Rx	1289db0e-5179-d157-e063-6294a90ab758	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	d1c2ec99-7183-46e3-a96e-4f23e20b8b06	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206528 application number: ANDA206528

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-070	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-070	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-070	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-070	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-071	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-071	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-071	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-071	Memantine Hydrochloride	Memantine Hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
63629-7333	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0346	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0346	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0346	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1899	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1899	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current