Application 078388

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	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
A078388-001	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL			2010-11-26
A078388-002	DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / 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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078388-001	DONEPEZIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078388-002	DONEPEZIL HYDROCHLORIDE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	2010-11-26	`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 3 · 52 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	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	12a755c5-1ad9-43d1-832a-eb2ff17bd693	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Cardinal Health 107, LLC	c942a4c9-dbe5-4131-bb6c-aa2d31b387e7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ee54a472-6783-41df-b8bb-9c3e4c996907	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8138f616-83f3-4c47-84ef-1bce2db339f7	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	41c095b6-acd9-4627-a813-bbca7ecafee5	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	56abe961-ec94-4a77-b548-426f6255539e	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Major Pharmaceuticals	c777ddc9-0b61-4d6f-95d6-818ba1861d62	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Torrent Pharmaceuticals Limited	76bf638e-dbde-418e-8977-1caf009990bc	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	6e9aacf9-abb6-4dec-9a8d-4eabf934d512	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1a8906ce-96dc-4bc8-81c1-5db67a187aac	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	American Health Packaging	12ae85f0-023c-49ca-8c4a-0a6a7585290e	2025-09-24	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	11404dc3-1bde-4d4e-8386-006b67ee19dd	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	de96349a-5fee-4de9-921c-e453d44b3203	2025-07-16	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	48178cb4-4fee-47c0-88e9-a4f017f1f448	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	042a59ea-131a-4806-b0f4-2f791d4414e2	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: donepezil hydrochloride generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	e2ab403a-ec2d-44e7-9da1-66d0a7443f1d	2025-06-05	Warnings, Adverse reactions	Name fallback brand name: Donepezil Hydrochloride generic name: DONEPEZIL HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31362	ORIG	2011-05-13