Application 016792

Type: NDA
Sponsor: ODYSSEY PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SURMONTIL	TRIMIPRAMINE MALEATE	CAPSULE;ORAL	EQ 25MG BASE	Yes	No
002	SURMONTIL	TRIMIPRAMINE MALEATE	CAPSULE;ORAL	EQ 50MG BASE	Yes	No
003	SURMONTIL	TRIMIPRAMINE MALEATE	CAPSULE;ORAL	EQ 100MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N016792-001	SURMONTIL	TRIMIPRAMINE MALEATE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N016792-002	SURMONTIL	TRIMIPRAMINE MALEATE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N016792-003	SURMONTIL	TRIMIPRAMINE MALEATE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15

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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016792-001	SURMONTIL	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016792-002	SURMONTIL	EQ 50MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016792-003	SURMONTIL	EQ 100MG BASE	CAPSULE / ORAL	RLD	1982-09-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016792-001	SURMONTIL	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016792-002	SURMONTIL	EQ 50MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016792-003	SURMONTIL	EQ 100MG BASE	CAPSULE / ORAL	RLD	1982-09-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016792-001	SURMONTIL	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016792-002	SURMONTIL	EQ 50MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016792-003	SURMONTIL	EQ 100MG BASE	CAPSULE / ORAL	RLD	1982-09-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1982-09-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1982-09-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1982-09-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016792-001	SURMONTIL	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016792-002	SURMONTIL	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016792-003	SURMONTIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1982-09-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016792-001	SURMONTIL	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016792-002	SURMONTIL	EQ 50MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016792-003	SURMONTIL	EQ 100MG BASE	CAPSULE / ORAL	RLD	1982-09-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016792-001	SURMONTIL	EQ 25MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016792-002	SURMONTIL	EQ 50MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`c0c555d07b60…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N016792-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016792-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016792-003	AB	1	`ea99ee380514…`

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	Name fallback generic name: TRIMIPRAMINE MALEATE
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Bryant Ranch Prepack	e4ff3409-f1bf-4851-a848-be1fcc4b1217	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRIMIPRAMINE MALEATE
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Bryant Ranch Prepack	479c7dc5-61e1-4bf2-b0bd-5d80865192af	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRIMIPRAMINE MALEATE
Trimipramine Maleate	TRIMIPRAMINE MALEATE	Elite Laboratories, Inc.	59c25dd3-7ab0-4e7f-b839-367db9eeccd2	2019-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRIMIPRAMINE MALEATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51285-538	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-538	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-538	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-539	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-539	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-539	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-554	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-554	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current
51285-554	Surmontil	Trimipramine Maleate	Teva Women's Health, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55392	SUPPL	2018-09-06
10925	SUPPL	2014-07-29
13033	SUPPL	2014-07-21
13032	SUPPL	2012-12-05
10924	SUPPL	2012-12-03
13031	SUPPL	2007-08-07
10923	SUPPL	2007-08-02
44009	ORIG	2007-05-09
10922	SUPPL	2005-01-13
495	SUPPL	2005-01-13
40726	SUPPL	2002-05-02
40725	SUPPL	2002-05-02
20064	SUPPL	2002-05-02
20063	SUPPL	2002-05-02