Application 211619

Type: ANDA
Sponsor: LEADING PHARMA LLC

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
A211619-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09
A211619-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09
A211619-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09
A211619-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09
A211619-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211619-001	AB
A211619-002	AB
A211619-003	AB
A211619-004	AB
A211619-005	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 · 175 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	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-03-09	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 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	A211619-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211619-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211619-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211619-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211619-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211619-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211619-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211619-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211619-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211619-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211619-005	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	e6a4cb10-1928-4abe-8797-404c9ddc37dd	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211619 application number: ANDA211619 ndc (product): 69315-159 ndc (product): 69315-162 ndc (product): 69315-158 ndc (product): 69315-160 ndc (product): 69315-161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69315-158	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-158	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-158	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-158	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-159	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-159	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-159	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-159	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-160	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-160	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-160	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-160	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-161	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-161	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-161	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-161	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-162	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-162	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-162	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-162	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Leading Pharma, LLC	ANDA	Current