Application 090048

Type: ANDA
Sponsor: DR REDDYS LABS 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 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
A090048-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-04-14
A090048-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2010-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090048-001	AB
A090048-002	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 · 82 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	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090048-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-04-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090048-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-04-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090048-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090048-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090048-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090048-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090048-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090048-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090048-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090048-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090048-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090048-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090048-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090048-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090048-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090048-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090048-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090048-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090048-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090048-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090048-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090048-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090048-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090048-002	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	d0a5e0fc-04e3-417d-bef3-9b309ff71597	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 0904-6506 ndc (product): 0904-6505
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	65c9e7bc-71f0-4113-8de1-4fcaa591735f	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 55154-4151 ndc (product): 55154-7637
Memantine	MEMANTINE	American Health Packaging	304a3059-4f7f-4ec4-839d-86492bb5e07b	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 60687-173 ndc (product): 60687-184
Memantine	MEMANTINE	NCS HealthCare of KY, LLC dba Vangard Labs	a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 0615-8192 ndc (product): 0615-8100
Memantine	MEMANTINE	NCS HealthCare of KY, LLC dba Vangard Labs	5c8a168d-aef5-4ac7-b8c1-3812a8c228ab	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 0615-8319
Memantine	MEMANTINE	NorthStar RxLLC	7a40ed9d-8853-b616-ff47-0c7b0fd28959	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 72603-118 ndc (product): 72603-119
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Dr. Reddys Laboratories Limited	a71e2482-5266-d03e-8b36-862afe78c9a4	2019-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090048 application number: ANDA090048 ndc (product): 55111-597 ndc (product): 55111-596

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8100	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8100	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8100	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8192	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8192	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8192	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8319	Memantine	Memantine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6505	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6505	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6505	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6505	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6506	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6506	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6506	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
0904-6506	Memantine	Memantine	Major Pharmaceuticals	ANDA	Current
55111-596	Memantine	Memantine	Dr. Reddys Laboratories Limited	ANDA	Current
55111-597	Memantine	Memantine	Dr. Reddys Laboratories Limited	ANDA	Current
55154-4151	Memantine	Memantine	Cardinal Health 107, LLC	ANDA	Current
55154-7637	Memantine	Memantine	Cardinal Health	ANDA	Current
55154-7637	Memantine	Memantine	Cardinal Health 107, LLC	ANDA	Current
55154-7637	Memantine	Memantine	Cardinal Health	ANDA	Current
55154-7637	Memantine	Memantine	Cardinal Health	ANDA	Current
60687-173	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-173	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-173	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-173	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-184	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-184	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-184	Memantine	Memantine	American Health Packaging	ANDA	Current
60687-184	Memantine	Memantine	American Health Packaging	ANDA	Current
70518-3297	Memantine	Memantine	REMEDYREPACK INC.	ANDA	Current
72603-118	Memantine	Memantine	NorthStar RxLLC	ANDA	Current
72603-119	Memantine	Memantine	NorthStar RxLLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31446	ORIG	2010-04-19