Application 208237

Type: ANDA
Sponsor: ANI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG;21MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2023-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208237-001	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.

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	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208237-001	MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-12-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208237-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208237-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208237-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208237-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208237-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208237-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208237-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208237-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208237-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208237-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208237-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208237-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208237-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208237-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208237-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208237-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208237-001	AB	1	`a50c72e98297…`

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 AND DONEPEZIL HYDROCHLORIDES	MEMANTINE AND DONEPEZIL HYDROCHLORIDES	ANI Pharmaceuticals, Inc.	c42a995d-cd0f-466c-8f47-43c7f32d9675	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208237 application number: ANDA208237

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77364	ORIG	2024-01-31