Application 071675

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG 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
A071675-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL			1988-01-05

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071675-001	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1988-01-05	`f41ea6bd6efb…`

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 4 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	A-S Medication Solutions	55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2	2024-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1cec730e-3218-ddf6-e063-6294a90a916e	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Epic Pharma, LLC	5f0f6fee-2497-4915-b58b-bf369efcfd79	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	890248d7-73b1-4ed3-b252-85775defdf34	2024-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9ee26b24-7121-3107-e053-2995a90ac61c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ec948b3d-4853-41bb-9f01-faf28fe369e5	2024-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	6e22050f-95ee-410a-b770-0c32fb8b321b	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	a4c804e3-4706-48d8-b928-b22c2dcaeed8	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	2cacce3a-4986-44a8-b4aa-6edb076d87bf	2023-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	0cbf87df-c447-4225-81f5-92c4bc3ef81d	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	7cfbb3d0-f19f-4977-ad0f-77676a8c6f83	2023-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	dd8d5edd-7b08-4061-86e6-c4179da89c0d	2023-08-17	Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	41046d94-1443-4bbd-96d0-8463604ae459	2023-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	14002bad-2577-436d-91ca-ec1b80ab0c97	2023-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	842b595b-dc54-4898-a178-1d2241cc065f	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DOXEPIN HYDROCHLORIDE generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	acb696a8-a74c-4c5d-9ce3-88f67558c2f2	2022-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	6ce7fde2-2d47-4238-9beb-555d352f4657	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	5b4dba99-6b66-4091-94f1-bf5f021c688a	2022-01-20	Warnings, Adverse reactions	Name fallback brand name: doxepin hydrochloride generic name: DOXEPIN HYDROCHLORIDE
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Florida Pharmaceutical Products, LLC	b787a283-f882-e1f0-e053-2a95a90a8975	2021-09-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Doxepin Hydrochloride generic name: DOXEPIN HYDROCHLORIDE
doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4a4eab1c-8e19-48f5-9216-09ab83eaa5f8	2021-06-01	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.