Application 212624

Type: ANDA
Sponsor: AJANTA PHARMA 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 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
A212624-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13
A212624-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212624-001	AB
A212624-002	AB
A212624-003	AB
A212624-004	AB
A212624-005	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 · 200 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	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2019-09-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 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	A212624-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212624-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212624-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212624-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212624-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212624-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212624-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212624-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212624-005	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	46be666a-fb9f-42a5-a55c-ea15fd5538c9	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624 ndc (product): 70518-3594
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Coupler LLC	54616c93-2325-4719-e063-6394a90a3910	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Coupler LLC	538643c0-b8d1-d71f-e063-6294a90a7734	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Ajanta Pharma USA Inc.	1513c98c-e7ef-4009-b932-6757048bb86a	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624 ndc (product): 27241-169 ndc (product): 27241-170 ndc (product): 27241-167 ndc (product): 27241-168 ndc (product): 27241-171
Doxepin HCL	DOXEPIN HCL	Direct_Rx	0ead9074-3478-7c3d-e063-6394a90a9d27	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	2cacce3a-4986-44a8-b4aa-6edb076d87bf	2023-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624 ndc (product): 71335-2188
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	0cbf87df-c447-4225-81f5-92c4bc3ef81d	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624 ndc (product): 71335-2092
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	7cfbb3d0-f19f-4977-ad0f-77676a8c6f83	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	41046d94-1443-4bbd-96d0-8463604ae459	2023-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624
Doxepin hydrochloride	DOXEPIN HYDROCHLORIDE	Proficient Rx LP	acb696a8-a74c-4c5d-9ce3-88f67558c2f2	2022-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212624 application number: ANDA212624 ndc (product): 71205-695

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-167	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-167	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-167	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-168	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-168	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-168	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-169	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-169	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-169	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-170	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-170	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-170	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-171	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma USA Inc.	ANDA	Current
27241-171	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
27241-171	Doxepin hydrochloride	Doxepin hydrochloride	Ajanta Pharma Limited	ANDA	Current
70518-3490	Doxepin hydrochloride	Doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3490	Doxepin hydrochloride	Doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3494	Doxepin hydrochloride	Doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3496	Doxepin hydrochloride	Doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3594	Doxepin hydrochloride	Doxepin hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-695	Doxepin hydrochloride	Doxepin hydrochloride	Proficient Rx LP	ANDA	Current
71335-2092	Doxepin hydrochloride	Doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2188	Doxepin hydrochloride	Doxepin hydrochloride	Bryant Ranch Prepack	ANDA	Current