Trimipramine Oral Capsule

Brand(s)
Surmontil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Women'S Health, Inc. (2015-02-09)
Oldest Current Product
1990-09-30
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TRIMIPRAMINE
FDAOB
ORAL\CAPSULE\TRIMIPRAMINE MALEATE
SPL Active
ORAL\CAPSULE\TRIMIPRAMINE MALEATE
SPL Moiety
ORAL\CAPSULE\TRIMIPRAMINE

product(s) by strength(s)

trimipramine 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850554SurmontilNDATeva Women'S Health, Inc.1990-09-30TRIMIPRAMINE MALEATEORALCAPSULENDA0167920177d783-773c-41bf-9db9-eb7e5c64474a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1459630295ANDAActavis Inc.2011-10-21TRIMIPRAMINE MALEATEORALCAPSULEANDA0773613e1e4157-bc15-4e2a-bb2a-ff41b2a8f905

trimipramine 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850538SurmontilNDATeva Women'S Health, Inc.1990-09-30TRIMIPRAMINE MALEATEORALCAPSULENDA0167920177d783-773c-41bf-9db9-eb7e5c64474a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1459630293ANDAActavis Inc.2011-11-21TRIMIPRAMINE MALEATEORALCAPSULEANDA0773613e1e4157-bc15-4e2a-bb2a-ff41b2a8f905

trimipramine 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850539SurmontilNDATeva Women'S Health, Inc.1990-09-30TRIMIPRAMINE MALEATEORALCAPSULENDA0167920177d783-773c-41bf-9db9-eb7e5c64474a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1459630294ANDAActavis Inc.2011-11-21TRIMIPRAMINE MALEATEORALCAPSULEANDA0773613e1e4157-bc15-4e2a-bb2a-ff41b2a8f905

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071283TRIMIPRAMINE MALEATETrueUSL PHARMA INC1987-12-08ANDA071283_001
2ANDA071284TRIMIPRAMINE MALEATETrueUSL PHARMA INC1987-12-08ANDA071284_001
3ANDA071285TRIMIPRAMINE MALEATETrueUSL PHARMA INC1987-12-08ANDA071285_001
4ANDA077361TRIMIPRAMINE MALEATEMIKAH PHARMA LLC2006-08-02ANDA077361_001, ANDA077361_002, ANDA077361_003
5NDA016792SURMONTILODYSSEY PHARMACEUTICALS INCNDA016792_001, NDA016792_002, NDA016792_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071283_001discontinuedTRIMIPRAMINE MALEATE (EQ 25MG BASE)ORALCAPSULEFalse1987-12-08TRIMIPRAMINE MALEATE
2ANDA071284_001discontinuedTRIMIPRAMINE MALEATE (EQ 50MG BASE)ORALCAPSULEFalse1987-12-08TRIMIPRAMINE MALEATE
3ANDA071285_001discontinuedTRIMIPRAMINE MALEATE (EQ 100MG BASE)ORALCAPSULEFalse1987-12-08TRIMIPRAMINE MALEATE
4ANDA077361_001RXTRIMIPRAMINE MALEATE (EQ 25MG BASE)ORALCAPSULEFalseAB2006-08-02TRIMIPRAMINE MALEATE
5ANDA077361_002RXTRIMIPRAMINE MALEATE (EQ 50MG BASE)ORALCAPSULEFalseAB2006-08-02TRIMIPRAMINE MALEATE
6ANDA077361_003RXTRIMIPRAMINE MALEATE (EQ 100MG BASE)ORALCAPSULEFalseAB2006-08-02TRIMIPRAMINE MALEATE
7NDA016792_001RXTRIMIPRAMINE MALEATE (EQ 25MG BASE)ORALCAPSULEFalseABSURMONTIL
8NDA016792_002RXTRIMIPRAMINE MALEATE (EQ 50MG BASE)ORALCAPSULETrueABSURMONTIL
9NDA016792_003RXTRIMIPRAMINE MALEATE (EQ 100MG BASE)ORALCAPSULEFalseAB1982-09-15SURMONTIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10177d783-773c-41bf-9db9-eb7e5c64474a (view SPL)SURMONTIL (Trimipramine Maleate) Rx onlyprescriptionHuman PrescriptionTeva Women'S Health, Inc.2015-02-095512850538, 512850539, 512850554
23e1e4157-bc15-4e2a-bb2a-ff41b2a8f905 (view SPL)TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx OnlyprescriptionHuman PrescriptionActavis Inc.MANUFACTURE2015-05-196459630293, 459630294, 459630295

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII