Application 215710

Type: ANDA
Sponsor: MANKIND PHARMA

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
A215710-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09
A215710-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215710-001	AB
A215710-002	AB
A215710-003	AB
A215710-004	AB
A215710-005	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 5 · 165 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	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2022-02-09	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 165 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	A215710-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215710-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215710-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215710-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215710-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215710-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215710-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215710-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215710-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215710-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215710-005	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	55f7d7b5-b747-49ac-9bf0-1510987b0291	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	First Nation Group, LLC	3d4f84a4-07a1-4d0e-85f5-dcd43b236a42	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710 ndc (product): 81469-416 ndc (product): 81469-417 ndc (product): 81469-415 ndc (product): 81469-419 ndc (product): 81469-418
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	NorthStar RxLLC	03cef3a6-a63d-4082-a491-451b24227d9d	2025-09-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Lifestar Pharma LLC	fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710 ndc (product): 70756-426 ndc (product): 70756-424 ndc (product): 70756-427 ndc (product): 70756-425 ndc (product): 70756-428
Doxepin HCL	DOXEPIN HCL	Direct_rx	249c8a57-fbec-47d5-e063-6394a90a6696	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215710 application number: ANDA215710
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	Exact identifier application applno (ANDA): 215710 application number: ANDA215710

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70756-424	Doxepin Hydrochloride	doxepin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-425	Doxepin Hydrochloride	doxepin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-426	Doxepin Hydrochloride	doxepin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-427	Doxepin Hydrochloride	doxepin hydrochloride	Lifestar Pharma LLC	ANDA	Current
70756-428	Doxepin Hydrochloride	doxepin hydrochloride	Lifestar Pharma LLC	ANDA	Current
81469-415	Doxepin Hydrochloride	doxepin hydrochloride	First Nation Group, LLC	ANDA	Current
81469-416	Doxepin Hydrochloride	doxepin hydrochloride	First Nation Group, LLC	ANDA	Current
81469-417	Doxepin Hydrochloride	doxepin hydrochloride	First Nation Group, LLC	ANDA	Current
81469-418	Doxepin Hydrochloride	doxepin hydrochloride	First Nation Group, LLC	ANDA	Current
81469-419	Doxepin Hydrochloride	doxepin hydrochloride	First Nation Group, LLC	ANDA	Current