Application 090058

Type: ANDA
Sponsor: SUN PHARM

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
A090058-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-05-05
A090058-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090058-001	AB
A090058-002	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	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090058-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090058-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-05-05	`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	A090058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090058-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090058-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090058-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090058-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090058-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090058-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090058-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090058-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090058-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090058-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090058-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090058-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090058-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090058-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090058-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090058-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090058-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090058-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090058-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090058-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090058-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090058-002	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	Bryant Ranch Prepack	2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090058 application number: ANDA090058 ndc (product): 71335-1908
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	d1963395-3cf7-4433-bf2c-06295bb1c5b0	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090058 application number: ANDA090058 ndc (product): 47335-321 ndc (product): 47335-322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-321	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-321	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-321	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-322	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-322	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-322	Memantine Hydrochloride	Memantine Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-4203	Memantine Hydrochloride	Memantine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4203	Memantine Hydrochloride	Memantine Hydrochloride	A-S Medication Solutions	ANDA	Current
67046-458	Memantine Hydrochloride	Memantine Hydrochloride	Contract Pharmacy Services-PA	ANDA	Current
71335-1908	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current