Application 203907

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

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
A203907-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-10-29
A203907-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2014-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203907-001	AB
A203907-002	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 · 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	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203907-001	DONEPEZIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203907-002	DONEPEZIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-10-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203907-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203907-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203907-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203907-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203907-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203907-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203907-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203907-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203907-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203907-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203907-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203907-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203907-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203907-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203907-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203907-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203907-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203907-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203907-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203907-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203907-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203907-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203907-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203907-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203907-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203907-002	AB	1	`782e0a99824c…`

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 · 2 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.	56abe961-ec94-4a77-b548-426f6255539e	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203907 application number: ANDA203907 ndc (product): 60429-322 ndc (product): 60429-321
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	6e9aacf9-abb6-4dec-9a8d-4eabf934d512	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203907 application number: ANDA203907 ndc (product): 50228-140 ndc (product): 50228-139

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-139	Donepezil hydrochloride	Donepezil	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-140	Donepezil hydrochloride	Donepezil	Camber Pharmaceuticals, Inc.	ANDA	Current
42543-702	Donepezil Hydrochloride	Donepezil Hydrochloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
42543-703	Donepezil Hydrochloride	Donepezil Hydrochloride	Vensun Pharmaceuticals, Inc.	ANDA	Current
50228-139	Donepezil Hydrochloride	Donepezil Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-139	Donepezil Hydrochloride	Donepezil Hydrochloride	ScieGen Pharmaceuticals,	ANDA	Current
50228-140	Donepezil Hydrochloride	Donepezil Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-140	Donepezil Hydrochloride	Donepezil Hydrochloride	ScieGen Pharmaceuticals,	ANDA	Current
60429-321	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply Inc	ANDA	Current
60429-321	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-321	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-322	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply Inc	ANDA	Current
60429-322	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current
60429-322	Donepezil Hydrochloride	Donepezil Hydrochloride	Golden State Medical Supply, Inc.	ANDA	Current