Application 203656

Type: ANDA
Sponsor: UNICHEM LABS 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 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
A203656-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL			2016-06-23
A203656-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL			2016-06-23

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	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2016-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203656-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL		2016-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203656-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL		2016-06-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203656-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203656-002	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A203656-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203656-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203656-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203656-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203656-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203656-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203656-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203656-002	AB	1	`ea99ee380514…`

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
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1a8906ce-96dc-4bc8-81c1-5db67a187aac	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203656 application number: ANDA203656 ndc (product): 29300-249 ndc (product): 29300-248

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-248	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (	ANDA	Current
29300-248	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-248	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-249	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (	ANDA	Current
29300-249	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-249	donepezil hydrochloride	donepezil hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current