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 3 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	Sun Pharmaceutical Industries, Inc.	554ab06f-6420-42b3-89d1-d97554c237d8	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Lifestar Pharma LLC	fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Mylan Institutional Inc.	137a953b-3c48-405f-86a6-ff778cb7f5f2	2025-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4920401a-cde5-404b-82aa-c3c0e8911065	2025-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	207bb11e-6029-4506-92d2-2d8a776b9408	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Doxepin	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	bc3b0401-df4a-46a2-a29b-3d70e72aa88b	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	66c6af99-9909-4b18-a43b-898a1c4a34d7	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin	DOXEPIN HYDROCHLORIDE	Strides Pharma Science Limited	399866d5-3fa6-46d0-9c62-492d5997bc4f	2025-03-21	Warnings, Adverse reactions	Name fallback generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	3bc72772-22ae-4f29-97ff-4a552b4df6d0	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	06e027bb-516d-4a1d-b5a0-a66c051eb367	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	direct rx	b56cdaee-6187-c763-e053-2995a90acc3f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2bf7d838-6274-4d8a-91cb-b27e1e81d273	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f900bac4-02f2-6bf3-e053-6394a90a2161	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Golden State Medical Supply, Inc.	00ef7d0b-4bb9-cd5b-e063-6294a90abc35	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	19c8ad61-4e4f-4c59-b196-34a4e470459f	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	13da67ec-370c-4647-8440-80fd55f1398e	2024-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	eb6954cf-e96b-4e54-961d-6b094384bac9	2024-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	214b6c28-7418-5ebd-e063-6394a90ae833	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	214bae5d-36e2-47ae-e063-6294a90a7ddd	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	efcae0f7-3491-470f-beea-1aff22178243	2024-08-20	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