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 5 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	Appco Pharma LLC	abf4c515-8888-4733-80a0-fd4e1cdb84a2	2021-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	e98f371e-f7fe-4c8f-9491-6eb4c53d43ad	2021-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Contract Pharmacal Corp.	abbf7078-a012-4e1a-e053-2995a90a792d	2020-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	10d9eba6-30d1-448a-8d92-a1a02df03303	2017-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
PRUDOXIN	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	ca53346b-8ab3-4722-98f6-cf272706d3fa	2017-06-29	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Zonalon	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	5f302247-525e-4acc-852b-00eb1d79af4b	2017-06-14	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b4771ea7-c19b-4182-bb23-c1473ab583fa	2017-05-24	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