Application 076786

Type: ANDA
Sponsor: SUN PHARM INDS 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 43.

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
A076786-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL			2010-11-26
A076786-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL			2010-11-26

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076786-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	2010-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076786-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	2010-11-26	`74a2ff9319b5…`

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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	bc570682-413b-46fb-a069-c2986884bfce	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	0c6b12e8-1933-40d8-bf43-97339b2b54fb	2023-01-18	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	Cadila Pharmaceuticals Limited	37aa1285-774a-4714-a4af-4e3fa9fa7f55	2022-12-27	Warnings, Adverse reactions	Name fallback brand name: DONEPEZIL HYDROCHLORIDE generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Proficient Rx LP	32709bda-53d0-4d57-9f0b-3e1f28e39f25	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Aricept	DONEPEZIL HYDROCHLORIDE	Eisai Inc.	98e451e1-e4d7-4439-a675-c5457ba20975	2021-12-30	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	9407258b-60ed-4884-a903-885aeedaddf8	2021-10-11	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	79ad107b-bb20-4ed3-89f0-d7c862f3957c	2018-10-31	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-128	Donepezil Hydrochloride	Donepezil Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-129	Donepezil Hydrochloride	Donepezil Hydrochloride	Ranbaxy Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8960	ORIG	2010-12-01