Application 208127

Type: ANDA
Sponsor: CROSSMEDIKA SA

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	Yes
003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208127-001	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15
A208127-002	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15
A208127-003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208127-001	AB
A208127-002	AB
A208127-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A208127-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208127-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208127-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208127-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimipramine	TRIMIPRAMINE	Breckenridge Pharmaceutical, Inc.	4f31df66-7dc2-1f04-e054-00144ff88e88	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208127 application number: ANDA208127 ndc (product): 51991-945 ndc (product): 51991-946 ndc (product): 51991-944

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-944	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-945	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-946	Trimipramine Maleate	Trimipramine Maleate	Breckenridge Pharmaceutical, Inc.	ANDA	Current