Application 203104

Type: ANDA
Sponsor: TWI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET;ORAL	23MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203104-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB		2014-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203104-001	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.

Product history page 1 of 2 · 42 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	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203104-001	DONEPEZIL HYDROCHLORIDE	23MG	TABLET / ORAL	AB	2014-10-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A203104-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203104-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203104-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203104-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203104-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203104-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203104-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203104-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203104-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203104-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203104-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203104-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203104-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203104-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203104-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203104-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203104-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203104-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203104-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203104-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203104-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203104-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203104-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203104-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203104-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203104-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203104-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203104-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203104-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203104-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203104-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203104-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203104-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203104-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203104-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203104-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203104-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203104-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203104-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203104-001	AB	1	`e64feba35796…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	a085ed33-c262-44ab-e053-2a95a90a5557	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104 ndc (product): 51407-320
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	12a755c5-1ad9-43d1-832a-eb2ff17bd693	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104 ndc (product): 24979-004
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	8090bff0-e0f0-4846-a2ab-cb28a0a2648d	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	caebc31c-5a35-4434-b7e2-80f6405383ca	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104 ndc (product): 63629-8483
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Proficient Rx LP	32709bda-53d0-4d57-9f0b-3e1f28e39f25	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203104 application number: ANDA203104 ndc (product): 71205-948

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-004	Donepezil Hydrochloride	Donepezil Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-004	Donepezil Hydrochloride	Donepezil Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-004	Donepezil Hydrochloride	Donepezil Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-004	Donepezil Hydrochloride	Donepezil Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
24979-004	Donepezil Hydrochloride	Donepezil Hydrochloride	TWi Pharmaceuticals, Inc.	ANDA	Current
42291-246	Donepezil Hydrochloride	donepezil hydrochloride	AvKARE, Inc.	ANDA	Current
42291-246	Donepezil Hydrochloride	donepezil hydrochloride	AvKARE, Inc.	ANDA	Current
42291-246	Donepezil Hydrochloride	donepezil hydrochloride	AvKARE	ANDA	Current
51407-320	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-320	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply	ANDA	Current
51407-320	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
63629-8483	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8483	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8483	Donepezil Hydrochloride	Donepezil Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71205-948	Donepezil Hydrochloride	Donepezil Hydrochloride	Proficient Rx LP	ANDA	Current
71205-948	Donepezil Hydrochloride	Donepezil Hydrochloride	Proficient Rx LP	ANDA	Current