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

NDC Listings For This Application#

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