Application 077361

Type: ANDA
Sponsor: ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	CAPSULE;ORAL	EQ 25MG BASE	No	No
002	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	CAPSULE;ORAL	EQ 50MG BASE	No	No
003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077361-001	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02
A077361-002	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02
A077361-003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077361-001	AB
A077361-002	AB
A077361-003	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 · 123 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	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2006-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB	2006-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077361-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2006-08-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077361-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077361-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077361-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077361-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077361-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077361-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077361-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077361-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077361-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077361-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077361-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077361-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077361-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077361-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077361-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077361-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077361-001	AB	1	`8072bd15b7f6…`

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
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Bryant Ranch Prepack	326ef804-8d3a-425e-8513-8c9811856aa0	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077361 application number: ANDA077361
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Bryant Ranch Prepack	e4ff3409-f1bf-4851-a848-be1fcc4b1217	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077361 application number: ANDA077361
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Bryant Ranch Prepack	479c7dc5-61e1-4bf2-b0bd-5d80865192af	2023-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077361 application number: ANDA077361
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Elite Laboratories, Inc.	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2019-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077361 application number: ANDA077361 ndc (product): 64850-852 ndc (product): 64850-851 ndc (product): 64850-850

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-802	Trimipramine Maleate	Trimipramine Maleate	Epic Pharma, LLC	ANDA	Current
42806-803	Trimipramine Maleate	Trimipramine Maleate	Epic Pharma, LLC	ANDA	Current
42806-804	Trimipramine Maleate	Trimipramine Maleate	Epic Pharma, LLC	ANDA	Current
64850-850	Trimipramine Maleate	Trimipramine Maleate	Elite Laboratories, Inc.	ANDA	Current
64850-851	Trimipramine Maleate	Trimipramine Maleate	Elite Laboratories, Inc.	ANDA	Current
64850-852	Trimipramine Maleate	Trimipramine Maleate	Elite Laboratories, Inc.	ANDA	Current
68462-804	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-804	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-805	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-805	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-806	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current
68462-806	Trimipramine Maleate	Trimipramine Maleate	Glenmark Pharmaceuticals Inc.,USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31229	ORIG	2006-08-07