Application 200022

Type: ANDA
Sponsor: UNICHEM 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
A200022-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2015-10-13
A200022-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200022-001	AB
A200022-002	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	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200022-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-10-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200022-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-10-13	`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	A200022-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200022-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200022-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200022-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200022-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200022-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200022-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200022-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200022-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200022-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200022-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200022-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200022-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200022-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200022-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200022-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200022-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200022-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200022-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200022-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200022-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200022-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200022-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200022-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200022-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200022-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200022-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200022-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200022-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	47e4a696-fe2a-c905-e063-6294a90a7415	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	AvPAK	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	ca619439-f4ca-43f1-9261-9aa2b6dc7450	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022 ndc (product): 50090-4434
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	2fdf0b2b-0337-472d-83ec-075c17c9b0d0	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022 ndc (product): 50090-5926
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90	2020-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200022 application number: ANDA200022 ndc (product): 29300-171 ndc (product): 29300-172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-171	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-171	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-171	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-172	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-172	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-172	Memantine Hydrochloride	memantine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
50090-4434	Memantine Hydrochloride	memantine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4434	Memantine Hydrochloride	memantine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4434	Memantine Hydrochloride	memantine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5926	Memantine Hydrochloride	memantine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5926	Memantine Hydrochloride	memantine hydrochloride	A-S Medication Solutions	ANDA	Current
63629-7397	Memantine Hydrochloride	memantine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7397	Memantine Hydrochloride	memantine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7732	Memantine Hydrochloride	memantine hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7732	Memantine Hydrochloride	memantine hydrochloride	Bryant Ranch Prepack	ANDA	Current