Application 201146

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL 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
A201146-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-08-17
A201146-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201146-001	AB
A201146-002	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	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2012-08-17	`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	A201146-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201146-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201146-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201146-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201146-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201146-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201146-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201146-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201146-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201146-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201146-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201146-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201146-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201146-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201146-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201146-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201146-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201146-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201146-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201146-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201146-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	7620f41a-3eef-453b-a564-ea3c85374de2	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 0615-8313
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	ac857917-74db-4591-be9f-d1c822c68c81	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 0615-7951 ndc (product): 0615-7952
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	4747633b-ac32-455e-8d50-ce9c481480c0	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 71335-0416
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	aa2c22b8-2dd4-4916-bc4f-9995eab74a6e	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 71335-2022
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	06dd25a5-1bf2-446d-ad75-ff9d55117660	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146 ndc (product): 33342-027 ndc (product): 33342-028
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0c6b12e8-1933-40d8-bf43-97339b2b54fb	2023-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201146 application number: ANDA201146

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7951	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7951	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7952	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7952	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8313	Donepezil Hydrochloride	Donepezil Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
33342-027	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-027	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-027	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-028	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-028	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-028	Donepezil Hydrochloride	Donepezil Hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-659	Donepezil Hydrochloride	Donepezil Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-171	Donepezil Hydrochloride	Donepezil Hydrochloride	American Health Packaging	ANDA	Current
61919-692	Donepezil Hydrochloride	Donepezil Hydrochloride	Direct Rx	ANDA	Current
63629-8050	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8050	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0416	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0416	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2022	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current