Application 215113

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No
004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 75MG BASE	No	No
005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	CAPSULE;ORAL	EQ 100MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215113-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24
A215113-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24
A215113-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24
A215113-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24
A215113-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215113-001	AB
A215113-002	AB
A215113-003	AB
A215113-004	AB
A215113-005	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 4 · 145 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	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-06-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 145 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	A215113-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215113-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215113-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215113-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215113-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215113-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215113-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215113-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215113-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215113-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215113-005	AB	1	`2680178bc6a6…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	2b1f0144-65d8-451f-8054-6be1675f102c	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113 ndc (product): 72205-088 ndc (product): 72205-091 ndc (product): 72205-092 ndc (product): 72205-090 ndc (product): 72205-089
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	d7a6768a-927b-4f51-858d-1ddfa9d5c5d3	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	e0460c02-3dae-4b19-845c-2ffcfb587f6d	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	94ee3c14-0ccc-4329-b012-63679a699a67	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	5ee0f8e6-df05-4166-a614-77e124db95ae	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	670edc2b-7914-479e-b4dd-d5c86706a631	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	d29a8c70-cf1c-4bf8-bb87-1c80babce64e	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	90d9041f-985b-470b-8cbb-f05dbfc770c9	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	99ff6e3e-8c12-4393-96ae-206d86d26947	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin HCL	DOXEPIN HCL	Direct_Rx	3a870ceb-5a95-9351-e063-6294a90a3027	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	13da67ec-370c-4647-8440-80fd55f1398e	2024-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	efcae0f7-3491-470f-beea-1aff22178243	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215113 application number: ANDA215113

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72205-088	Doxepin Hydrochloride	Doxepin Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-089	Doxepin Hydrochloride	Doxepin Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-090	Doxepin Hydrochloride	Doxepin Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-091	Doxepin Hydrochloride	Doxepin Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-092	Doxepin Hydrochloride	Doxepin Hydrochloride	Novadoz Pharmaceuticals LLC	ANDA	Current