Application 215076

Type: ANDA
Sponsor: ALEMBIC PHARMS 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
A215076-001	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-002	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-003	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-004	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21
A215076-005	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215076-001	AB
A215076-002	AB
A215076-003	AB
A215076-004	AB
A215076-005	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 · 170 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	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-001	DOXEPIN HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-002	DOXEPIN HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-003	DOXEPIN HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-004	DOXEPIN HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-005	DOXEPIN HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2021-04-21	`2680178bc6a6…`

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
2026-08-18 06:07:40	2026-07	A215076-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215076-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215076-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215076-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215076-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215076-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215076-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215076-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215076-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215076-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215076-005	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 · 10 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	09a70f17-f934-4b4b-9277-6351d906ab47	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	REMEDYREPACK INC.	21dc77be-23af-4a1f-b189-dfee8ae2f894	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	4920401a-cde5-404b-82aa-c3c0e8911065	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076 ndc (product): 62332-640 ndc (product): 62332-645 ndc (product): 62332-639 ndc (product): 62332-638 ndc (product): 62332-637
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	06e027bb-516d-4a1d-b5a0-a66c051eb367	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Bryant Ranch Prepack	19c8ad61-4e4f-4c59-b196-34a4e470459f	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
Doxepin HCL	DOXEPIN HCL	Direct_rx	21c64f9f-cee2-60b0-e063-6294a90ae97e	2024-09-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	214bae5d-36e2-47ae-e063-6294a90a7ddd	2024-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	1cec730e-3218-ddf6-e063-6294a90a916e	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	A-S Medication Solutions	890248d7-73b1-4ed3-b252-85775defdf34	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076
DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	842b595b-dc54-4898-a178-1d2241cc065f	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215076 application number: ANDA215076 ndc (product): 46708-637 ndc (product): 46708-638 ndc (product): 46708-640 ndc (product): 46708-639 ndc (product): 46708-645

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-637	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-638	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-639	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-640	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
46708-645	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ANDA	Current
62332-637	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-637	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-638	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-638	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-639	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-639	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-640	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-640	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-645	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-645	DOXEPIN HYDROCHLORIDE	DOXEPIN HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	ANDA	Current