Application 202761

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	TABLET; ORAL	3MG	No	No
002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	TABLET; ORAL	6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202761-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2023-08-16
A202761-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB		2023-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202761-001	AB
A202761-002	AB

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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2023-08-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2023-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202761-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2023-08-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202761-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2023-08-16	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202761-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202761-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202761-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202761-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202761-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202761-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202761-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202761-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202761-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202761-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202761-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202761-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202761-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202761-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202761-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202761-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202761-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202761-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202761-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202761-002	AB	1	`d06236e962d9…`
2023-12-20 04:57 UTC	2023-12	A202761-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202761-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202761-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202761-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202761-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202761-002	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202761-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202761-002	AB	1	`a50c72e98297…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
doxepin	DOXEPIN	Zydus Lifesciences Limited	1461ede6-24f0-42a1-b801-0cf4ef404985	2025-01-08		Exact identifier application applno (ANDA): 202761 application number: ANDA202761
doxepin	DOXEPIN	Viona Pharmaceuticals Inc	3377541d-db46-4fd9-9a4b-faa5f6108e67	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202761 application number: ANDA202761