Application 202337

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	TABLET;ORAL	EQ 3MG BASE	No	No
002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	TABLET;ORAL	EQ 6MG BASE	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
A202337-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB		2016-01-20
A202337-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB		2016-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202337-001	AB
A202337-002	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 3 · 84 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	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL		2016-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL		2016-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202337-001	DOXEPIN HYDROCHLORIDE	EQ 3MG BASE	TABLET / ORAL	AB	2016-01-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202337-002	DOXEPIN HYDROCHLORIDE	EQ 6MG BASE	TABLET / ORAL	AB	2016-01-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202337-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202337-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202337-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202337-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202337-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202337-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202337-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202337-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202337-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202337-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202337-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202337-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202337-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202337-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202337-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202337-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202337-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202337-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202337-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202337-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202337-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202337-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202337-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202337-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202337-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202337-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202337-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202337-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202337-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202337-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202337-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202337-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202337-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202337-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202337-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202337-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202337-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202337-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202337-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202337-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin	DOXEPIN	North Star Rx LLC	12edd5c6-c863-b83a-e063-6294a90a2f36	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202337 application number: ANDA202337
Doxepin	DOXEPIN	Marlex Pharmaceuticals, Inc.	06e79a65-1455-804e-e063-6394a90a2f3d	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202337 application number: ANDA202337
Doxepin	DOXEPIN	Archis Pharma LLC	e3eac8e4-224e-4b7b-81d3-071301f914fa	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202337 application number: ANDA202337 ndc (product): 72819-162 ndc (product): 72819-161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5390	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5390	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5390	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5391	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5391	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5391	Doxepin Hydrochloride	doxepin hydrochloride	Mylan Pharmaceuticals Inc.	ANDA	Current
72819-161	Doxepin	Doxepin	Archis Pharma LLC	ANDA	Current
72819-162	Doxepin	Doxepin	Archis Pharma LLC	ANDA	Current