Application 213063

Type: ANDA
Sponsor: TARO PHARM INDS LTD

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 1.

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	Approval date
A213063-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	2020-07-01
A213063-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	2020-07-01
A213063-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	2020-07-01
A213063-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	2020-07-01
A213063-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	2020-07-01

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 · 185 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
2026-02-19 14:30 UTC	2026-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL		2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2020-07-01	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A213063-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213063-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213063-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213063-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213063-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213063-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213063-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213063-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213063-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213063-005	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin HCL	DOXEPIN HCL	Direct_Rx	dea965fe-6b54-bbf0-e053-2a95a90a1003	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (product): 72189-355
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	direct rx	b56cdaee-6187-c763-e053-2995a90acc3f	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (product): 72189-161
Doxepin Hydrochloride	DOXEPIN HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f900bac4-02f2-6bf3-e053-6394a90a2161	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	55a20aa1-fc9e-487d-9f8d-c4abf77ae2d2	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213063 application number: ANDA213063 ndc (product): 50090-5286

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-132	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NORTHSTAR RX LLC	ANDA	Current
16714-133	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NORTHSTAR RX LLC	ANDA	Current
16714-134	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NORTHSTAR RX LLC	ANDA	Current
16714-135	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NORTHSTAR RX LLC	ANDA	Current
16714-136	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NORTHSTAR RX LLC	ANDA	Current
50090-5286	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
51672-4217	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4218	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4219	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4220	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4221	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55700-917	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Quality Care Products, LLC	ANDA	Current
55700-928	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Quality Care Products, LLC	ANDA	Current
68071-2356	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2949	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2949	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2949	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2984	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3017	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3017	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3020	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-3020	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71335-1704	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1704	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1770	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-2028	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
72189-161	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	direct rx	ANDA	Current
72189-355	Doxepin HCL	Doxepin HCL	Direct_Rx	ANDA	Current
72189-355	Doxepin HCL	Doxepin HCL	Direct_Rx	ANDA	Current