Application 040751

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040751-001	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28
A040751-002	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28
A040751-003	IMIPRAMINE HYDROCHLORIDE	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040751-001	AB
A040751-002	AB
A040751-003	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 4 · 126 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	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-002	IMIPRAMINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-003	IMIPRAMINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040751-001	IMIPRAMINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2008-02-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A040751-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040751-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040751-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040751-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040751-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040751-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040751-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040751-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040751-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040751-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040751-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040751-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040751-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040751-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040751-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040751-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040751-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040751-001	AB	1	`1e350fbaab3a…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	830cb1cb-20a1-4617-a748-24241257a244	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751 ndc (product): 72789-240 ndc (product): 72789-244 ndc (product): 72789-243
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	REMEDYREPACK INC.	02c19a0a-3d9d-4881-ad14-1687aafd87b5	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751 ndc (product): 70518-3526
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	a5f60cf1-6f14-40a3-a794-9d69b28088d8	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751 ndc (product): 69584-425 ndc (product): 69584-427 ndc (product): 69584-426
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Proficient Rx LP	5997822f-ce83-4091-be71-21a6b01caaba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	fd78fb8e-99ae-91b0-e053-6394a90a9271	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	Key Therapeutics	9c685c94-64cd-442a-ade7-193c62d7a058	2024-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751 ndc (product): 70868-810
Imipramine Hydrochloride	IMIPRAMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	209cc339-658a-577a-e063-6394a90a2b47	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040751 application number: ANDA040751

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-2022	Imipramine Hydrochloride	Imipramine Hydrochloride	Unit Dose Services	ANDA	Current
69584-425	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-425	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-425	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-425	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-426	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-426	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-426	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-426	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-427	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-427	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-427	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-427	Imipramine Hydrochloride	Imipramine Hydrochloride	Oxford Pharmaceuticals, LLC	ANDA	Current
70518-3438	Imipramine Hydrochloride	Imipramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3526	Imipramine Hydrochloride	Imipramine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70868-810	Imipramine Hydrochloride	Imipramine Hydrochloride	Key Therapeutics	ANDA	Current
72789-240	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-240	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-240	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-240	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-243	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-243	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-243	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-243	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-244	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-244	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-244	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-244	Imipramine Hydrochloride	Imipramine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53938	ORIG	2018-05-01