Application 213796

Type: ANDA
Sponsor: EDENBRIDGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213796-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL			2022-04-19

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-04-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213796-001	DOXEPIN HYDROCHLORIDE	EQ 150MG BASE	CAPSULE / ORAL		2022-04-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213796-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213796-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213796-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213796-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213796-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213796-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213796-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213796-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213796-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213796-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213796-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213796-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213796-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213796-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213796-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213796-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213796-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213796-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213796-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213796-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213796-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213796-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213796-001	AB	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213796-001	CGT	2022-10-29	`5c6f7cd8ea54…`
2023-01-26 05:58 UTC	2023-01	A213796-001	CGT	2022-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213796-001	CGT	2022-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213796-001	CGT	2022-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213796-001	CGT	2022-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213796-001	CGT	2022-10-29	`cb3db0bc1861…`

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 2 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Safecor Health, LLC	a2297f75-c498-419b-aa29-057271313a7f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1ede17e6-19e9-455c-ad16-8029a590735c	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d2a91b99-513d-4894-ad6d-02d2028a2290	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	e6a4cb10-1928-4abe-8797-404c9ddc37dd	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	d5df4beb-8048-4b83-aa59-19876437001d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1496dfc1-de50-471c-be87-1f1e2b70ab5a	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	e0460c02-3dae-4b19-845c-2ffcfb587f6d	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Redpharm Drug	37451a61-ccb1-57b3-e063-6294a90a2592	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Chartwell RX, LLC	33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Ajanta Pharma USA Inc.	1513c98c-e7ef-4009-b932-6757048bb86a	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	8f7e9677-cc84-414b-8eb8-33993d285bb3	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	09a70f17-f934-4b4b-9277-6351d906ab47	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	55f7d7b5-b747-49ac-9bf0-1510987b0291	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	1533343b-f1ed-4c3a-bb36-23a748452b05	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	94ee3c14-0ccc-4329-b012-63679a699a67	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	First Nation Group, LLC	3d4f84a4-07a1-4d0e-85f5-dcd43b236a42	2025-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NorthStar RxLLC	03cef3a6-a63d-4082-a491-451b24227d9d	2025-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Major Pharmaceuticals	df3b6be0-6a64-4174-b351-dab2061f290e	2025-09-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	89ed6385-cf6a-458e-81ea-c7f3fead41c5	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aurobindo Pharma Limited	f3c242dd-426e-4c69-8f21-2645361d5f27	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42799-935	Doxepin Hydrochloride	Doxepin Hydrochloride	Edenbridge Pharmaceuticals LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71915	ORIG	2022-08-26