FDA.reportPublic FDA data

Application 016792

Type
NDA
Sponsor
ODYSSEY PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SURMONTILTRIMIPRAMINE MALEATECAPSULE;ORALEQ 25MG BASEYesNo
002SURMONTILTRIMIPRAMINE MALEATECAPSULE;ORALEQ 50MG BASEYesNo
003SURMONTILTRIMIPRAMINE MALEATECAPSULE;ORALEQ 100MG BASEYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016792-001SURMONTILTRIMIPRAMINE MALEATEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N016792-002SURMONTILTRIMIPRAMINE MALEATEEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N016792-003SURMONTILTRIMIPRAMINE MALEATEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1982-09-15

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N016792-001SURMONTILEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016792-002SURMONTILEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016792-003SURMONTILEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1982-09-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016792-001SURMONTILEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016792-002SURMONTILEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016792-003SURMONTILEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1982-09-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016792-001SURMONTILEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016792-002SURMONTILEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016792-003SURMONTILEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1982-09-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016792-001SURMONTILEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016792-002SURMONTILEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016792-003SURMONTILEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1982-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N016792-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N016792-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N016792-003AB1ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepack326ef804-8d3a-425e-8513-8c9811856aa02023-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIMIPRAMINE MALEATE
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepacke4ff3409-f1bf-4851-a848-be1fcc4b12172023-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIMIPRAMINE MALEATE
Trimipramine MaleateTRIMIPRAMINE MALEATEBryant Ranch Prepack479c7dc5-61e1-4bf2-b0bd-5d80865192af2023-06-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRIMIPRAMINE MALEATE
Trimipramine MaleateTRIMIPRAMINE MALEATEElite Laboratories, Inc.59c25dd3-7ab0-4e7f-b839-367db9eeccd22019-12-29Boxed warning, Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51285-538SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-538SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-538SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-539SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-539SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-539SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-554SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-554SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent
51285-554SurmontilTrimipramine MaleateTeva Women's Health, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55392SUPPL2018-09-06
10925SUPPL2014-07-29
13033SUPPL2014-07-21
13032SUPPL2012-12-05
10924SUPPL2012-12-03
13031SUPPL2007-08-07
10923SUPPL2007-08-02
44009ORIG2007-05-09
10922SUPPL2005-01-13
495SUPPL2005-01-13
40726SUPPL2002-05-02
40725SUPPL2002-05-02
20064SUPPL2002-05-02
20063SUPPL2002-05-02