Application 211100

Type: ANDA
Sponsor: YICHANG HUMANWELL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7MG	No	No
002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	14MG	No	No
003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	21MG	No	No
004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	28MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211100-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02
A211100-004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211100-001	AB
A211100-002	AB
A211100-003	AB
A211100-004	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 4 · 144 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
2026-09-14 22:38:34	2026-08	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-001	MEMANTINE HYDROCHLORIDE	7MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-002	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-003	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211100-004	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-04-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211100-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211100-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211100-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211100-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211100-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211100-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211100-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211100-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211100-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211100-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211100-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211100-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211100-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211100-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211100-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211100-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211100-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211100-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211100-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211100-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211100-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211100-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211100-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211100-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211100-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211100-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211100-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211100-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211100-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211100-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211100-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211100-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211100-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211100-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211100-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	a74050c4-5a37-4fa1-85d9-85831525cfeb	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211100 application number: ANDA211100 ndc (product): 70436-057 ndc (product): 70436-054 ndc (product): 70436-055 ndc (product): 70436-056

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70436-054	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-054	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-054	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-055	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-055	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-055	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-056	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-056	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-056	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-057	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-057	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current
70436-057	Memantine Hydrochloride	memantine hydrochloride	Slate Run Pharmaceuticals, LLC	ANDA	Current