Imipramine Oral Capsule

Brand(s)
Tofranil-PM
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt, Inc. (2013-04-30)
Oldest Current Product
2009-10-15
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\IMIPRAMINE
FDAOB
ORAL\CAPSULE\IMIPRAMINE PAMOATE
SPL Active
ORAL\CAPSULE\IMIPRAMINE PAMOATE
SPL Moiety
ORAL\CAPSULE\IMIPRAMINE

product(s) by strength(s)

imipramine pamoate 100 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069932NDAMallinckrodt, Inc.2009-10-15IMIPRAMINE PAMOATEORALCAPSULENDA01709075c986bd-e51f-4f8c-9590-0df4718d0b9e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540274ANDARoxane Laboratories, Inc2010-04-19IMIPRAMINE PAMOATEORALCAPSULEANDA0910996e780825-2a66-41fd-a04c-78fa7c4df05e

imipramine pamoate 125 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069933NDAMallinckrodt, Inc.2009-10-15IMIPRAMINE PAMOATEORALCAPSULENDA01709075c986bd-e51f-4f8c-9590-0df4718d0b9e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540275ANDARoxane Laboratories, Inc2010-04-19IMIPRAMINE PAMOATEORALCAPSULEANDA0910996e780825-2a66-41fd-a04c-78fa7c4df05e

imipramine pamoate 150 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069934NDAMallinckrodt, Inc.2009-10-15IMIPRAMINE PAMOATEORALCAPSULENDA01709075c986bd-e51f-4f8c-9590-0df4718d0b9e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540276ANDARoxane Laboratories, Inc2010-04-19IMIPRAMINE PAMOATEORALCAPSULEANDA0910996e780825-2a66-41fd-a04c-78fa7c4df05e

imipramine pamoate 75 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069931NDAMallinckrodt, Inc.2009-10-15IMIPRAMINE PAMOATEORALCAPSULENDA01709075c986bd-e51f-4f8c-9590-0df4718d0b9e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540273ANDARoxane Laboratories, Inc2010-04-19IMIPRAMINE PAMOATEORALCAPSULEANDA0910996e780825-2a66-41fd-a04c-78fa7c4df05e
2681800314ANDALupin Pharmaceuticals, Inc.2010-04-16IMIPRAMINE PAMOATEORALCAPSULEANDA090444d1dde497-1889-4424-af18-da7ca6459cf3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900963NDAStat Rx Usa Llc2009-10-15IMIPRAMINE PAMOATEORALCAPSULE004069931NDA01709053faac6a-fdb9-4d60-814d-b4aab9c9da58

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA090444IMIPRAMINE PAMOATELUPIN LTD2010-04-16ANDA090444_001, ANDA090444_002, ANDA090444_003, ANDA090444_004
2ANDA091099IMIPRAMINE PAMOATEROXANE LABORATORIES INC2010-04-16ANDA091099_001, ANDA091099_002, ANDA091099_003, ANDA091099_004
3ANDA202338IMIPRAMINE PAMOATEMYLAN PHARMACEUTICALS INC2013-06-28ANDA202338_001, ANDA202338_002, ANDA202338_003, ANDA202338_004
4NDA017090TOFRANIL-PMMALLINCKRODT INCNDA017090_001, NDA017090_002, NDA017090_003, NDA017090_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA090444_001RXIMIPRAMINE PAMOATE (EQ 75MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
2ANDA090444_002RXIMIPRAMINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
3ANDA090444_003RXIMIPRAMINE PAMOATE (EQ 125MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
4ANDA090444_004RXIMIPRAMINE PAMOATE (EQ 150MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
5ANDA091099_001RXIMIPRAMINE PAMOATE (EQ 75MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
6ANDA091099_002RXIMIPRAMINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
7ANDA091099_003RXIMIPRAMINE PAMOATE (EQ 125MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
8ANDA091099_004RXIMIPRAMINE PAMOATE (EQ 150MG HCL)ORALCAPSULEFalseAB2010-04-16IMIPRAMINE PAMOATE
9ANDA202338_001RXIMIPRAMINE PAMOATE (EQ 75MG HCL)ORALCAPSULEFalseAB2013-06-28IMIPRAMINE PAMOATE
10ANDA202338_002RXIMIPRAMINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseAB2013-06-28IMIPRAMINE PAMOATE
11ANDA202338_003RXIMIPRAMINE PAMOATE (EQ 125MG HCL)ORALCAPSULEFalseAB2013-06-28IMIPRAMINE PAMOATE
12ANDA202338_004RXIMIPRAMINE PAMOATE (EQ 150MG HCL)ORALCAPSULEFalseAB2013-06-28IMIPRAMINE PAMOATE
13NDA017090_001RXIMIPRAMINE PAMOATE (EQ 75MG HCL)ORALCAPSULETrueABTOFRANIL-PM
14NDA017090_002RXIMIPRAMINE PAMOATE (EQ 150MG HCL)ORALCAPSULEFalseABTOFRANIL-PM
15NDA017090_003RXIMIPRAMINE PAMOATE (EQ 125MG HCL)ORALCAPSULEFalseABTOFRANIL-PM
16NDA017090_004RXIMIPRAMINE PAMOATE (EQ 100MG HCL)ORALCAPSULEFalseABTOFRANIL-PM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
153faac6a-fdb9-4d60-814d-b4aab9c9da58 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-251165900963
26e780825-2a66-41fd-a04c-78fa7c4df05e (view SPL)IMIPRAMINE PAMOATE Capsules Rx onlyprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2014-03-123000540273, 000540274, 000540275, 000540276
375bf3473-2d70-4d41-93cd-afa1015e45bb (view SPL)Tofranil-PM(imipramine pamoate) capsules(75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.MANUFACTURE2014-06-3010004069923, 004069924, 004069925, 004069926
475c986bd-e51f-4f8c-9590-0df4718d0b9e (view SPL)Imipramine Pamoate Capsules (75 mg, 100 mg, 125 mg and 150 mg) For oral administration Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.MANUFACTURE2013-04-305004069931, 004069932, 004069933, 004069934
5d1dde497-1889-4424-af18-da7ca6459cf3 (view SPL)For oral administration Rx onlyprescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-06-066681800314

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