Clomipramine Oral Capsule

Brand(s)
Anafranil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt, Inc. (2015-01-01)
Oldest Current Product
1996-03-29
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\CLOMIPRAMINE
FDAOB
ORAL\CAPSULE\CLOMIPRAMINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\CLOMIPRAMINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\CLOMIPRAMINE

product(s) by strength(s)

clomipramine hydrochloride 25 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068806NDAMallinckrodt, Inc.2015-06-01CLOMIPRAMINE HYDROCHLORIDEORALCAPSULENDA019906d7cee3fa-d05c-4702-8f75-f446627bdb49

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783025ANDAMylan Pharmaceuticals Inc.1998-05-11CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0749477ffd89f1-43ae-4092-8575-d404311da716
2007812027ANDASandoz Inc1996-03-29CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0743643823106e-6be3-4154-a607-caa3a69dc75c
3516724011ANDATaro Pharmaceuticals U.S.A., Inc.1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA074694db752dbd-be41-4cdd-8a13-ed1ff9ef7461

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630257ANDAPd-Rx Pharmaceuticals, Inc.2009-08-06CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE003783025ANDA0749473c67bab7-783a-4943-944e-938395b1c3cb
2604290287Golden State Medical Supply, Inc.CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE5167240114c32971e-feb3-4388-9cd6-d1f99f258b0d
3636292756ANDABryant Ranch Prepack1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724011ANDA074694d0ffac35-c1b3-4f2d-8f11-c99b37e9cca3
4680840818ANDAAmerican Health Packaging2014-08-29CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724011ANDA0746941809bcb4-5fcc-45ca-986a-4fa5edcd4b5e
5681513048ANDACarilion Materials Management1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724011ANDA07469429ec40d4-3d15-436f-b15f-f940ce454d5b

clomipramine hydrochloride 50 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068807NDAMallinckrodt, Inc.2015-06-01CLOMIPRAMINE HYDROCHLORIDEORALCAPSULENDA019906d7cee3fa-d05c-4702-8f75-f446627bdb49

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783050ANDAMylan Pharmaceuticals Inc.1998-05-11CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0749477ffd89f1-43ae-4092-8575-d404311da716
2007812037ANDASandoz Inc1996-03-29CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0743643823106e-6be3-4154-a607-caa3a69dc75c
3516724012ANDATaro Pharmaceuticals U.S.A., Inc.1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA074694db752dbd-be41-4cdd-8a13-ed1ff9ef7461

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157591ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724012ANDA07469475347df1-105c-45a2-9c4d-36f3340feac6
2548684023ANDAPhysicians Total Care, Inc.2005-09-28CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724012ANDA07469433c772f8-08f0-4f99-8fbd-4de48ad82d89
3604290289Golden State Medical Supply, Inc.CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE5167240125af7ec26-5666-41a9-a0a9-1c3b09f6638e
4636294123ANDABryant Ranch Prepack1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724012ANDA07469432f05aed-18b6-4269-b10c-5d10f5bf7ca2
5680840790ANDAAmerican Health Packaging2014-09-15CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE516724012ANDA0746941809bcb4-5fcc-45ca-986a-4fa5edcd4b5e

clomipramine hydrochloride 75 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068808NDAMallinckrodt, Inc.2015-06-01CLOMIPRAMINE HYDROCHLORIDEORALCAPSULENDA019906d7cee3fa-d05c-4702-8f75-f446627bdb49

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783075ANDAMylan Pharmaceuticals Inc.1998-05-11CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0749477ffd89f1-43ae-4092-8575-d404311da716
2007812047ANDASandoz Inc1996-03-29CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA0743643823106e-6be3-4154-a607-caa3a69dc75c
3516724013ANDATaro Pharmaceuticals U.S.A., Inc.1996-12-31CLOMIPRAMINE HYDROCHLORIDEORALCAPSULEANDA074694db752dbd-be41-4cdd-8a13-ed1ff9ef7461

relabeler product(s)(s)

#idlabeleractive ingredient(s)routedose formequivalent productspl
1604290288Golden State Medical Supply, Inc.CLOMIPRAMINE HYDROCHLORIDEORALCAPSULE5167240134c32971e-feb3-4388-9cd6-d1f99f258b0d

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074364CLOMIPRAMINE HYDROCHLORIDESANDOZ INC1996-03-29ANDA074364_001, ANDA074364_002, ANDA074364_003
2ANDA074600CLOMIPRAMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1996-11-27ANDA074600_001, ANDA074600_002, ANDA074600_003
3ANDA074694CLOMIPRAMINE HYDROCHLORIDETARO PHARMACEUTICAL INDUSTRIES LTD1996-12-31ANDA074694_001, ANDA074694_002, ANDA074694_003
4ANDA074751CLOMIPRAMINE HYDROCHLORIDETrueWATSON LABORATORIES INC1998-09-30ANDA074751_001, ANDA074751_002, ANDA074751_003
5ANDA074849CLOMIPRAMINE HYDROCHLORIDETrueTEVA PHARMACEUTICALS USA INC1997-04-04ANDA074849_001, ANDA074849_002, ANDA074849_003
6ANDA074947CLOMIPRAMINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1998-04-30ANDA074947_001, ANDA074947_002, ANDA074947_003
7ANDA074953CLOMIPRAMINE HYDROCHLORIDETrueSANDOZ INC1997-06-25ANDA074953_001, ANDA074953_002, ANDA074953_003
8ANDA074958CLOMIPRAMINE HYDROCHLORIDETEVA PHARMACEUTICALS USA INC1997-08-26ANDA074958_001, ANDA074958_002, ANDA074958_003
9NDA019906ANAFRANILMALLINCKRODT LLC1989-12-29NDA019906_001, NDA019906_002, NDA019906_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074364_001RXCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalseAB1996-03-29CLOMIPRAMINE HYDROCHLORIDE
2ANDA074364_002RXCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalseAB1996-03-29CLOMIPRAMINE HYDROCHLORIDE
3ANDA074364_003RXCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalseAB1996-03-29CLOMIPRAMINE HYDROCHLORIDE
4ANDA074600_001discontinuedCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalse1996-11-27CLOMIPRAMINE HYDROCHLORIDE
5ANDA074600_002discontinuedCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalse1996-11-27CLOMIPRAMINE HYDROCHLORIDE
6ANDA074600_003discontinuedCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalse1996-11-27CLOMIPRAMINE HYDROCHLORIDE
7ANDA074694_001RXCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalseAB1996-12-31CLOMIPRAMINE HYDROCHLORIDE
8ANDA074694_002RXCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalseAB1996-12-31CLOMIPRAMINE HYDROCHLORIDE
9ANDA074694_003RXCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalseAB1996-12-31CLOMIPRAMINE HYDROCHLORIDE
10ANDA074751_001discontinuedCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalse1998-09-30CLOMIPRAMINE HYDROCHLORIDE
11ANDA074751_002discontinuedCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalse1998-09-30CLOMIPRAMINE HYDROCHLORIDE
12ANDA074751_003discontinuedCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalse1998-09-30CLOMIPRAMINE HYDROCHLORIDE
13ANDA074849_001discontinuedCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalse1997-04-04CLOMIPRAMINE HYDROCHLORIDE
14ANDA074849_002discontinuedCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalse1997-04-04CLOMIPRAMINE HYDROCHLORIDE
15ANDA074849_003discontinuedCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalse1997-04-04CLOMIPRAMINE HYDROCHLORIDE
16ANDA074947_001RXCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalseAB1998-04-30CLOMIPRAMINE HYDROCHLORIDE
17ANDA074947_002RXCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalseAB1998-04-30CLOMIPRAMINE HYDROCHLORIDE
18ANDA074947_003RXCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalseAB1998-04-30CLOMIPRAMINE HYDROCHLORIDE
19ANDA074953_001discontinuedCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalse1997-06-25CLOMIPRAMINE HYDROCHLORIDE
20ANDA074953_002discontinuedCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalse1997-06-25CLOMIPRAMINE HYDROCHLORIDE
21ANDA074953_003discontinuedCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalse1997-06-25CLOMIPRAMINE HYDROCHLORIDE
22ANDA074958_001RXCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalseAB1997-08-26CLOMIPRAMINE HYDROCHLORIDE
23ANDA074958_002RXCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULEFalseAB1997-08-26CLOMIPRAMINE HYDROCHLORIDE
24ANDA074958_003RXCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalseAB1997-08-26CLOMIPRAMINE HYDROCHLORIDE
25NDA019906_001RXCLOMIPRAMINE HYDROCHLORIDE (25MG)ORALCAPSULEFalseAB1989-12-29ANAFRANIL
26NDA019906_002RXCLOMIPRAMINE HYDROCHLORIDE (50MG)ORALCAPSULETrueAB1989-12-29ANAFRANIL
27NDA019906_003RXCLOMIPRAMINE HYDROCHLORIDE (75MG)ORALCAPSULEFalseAB1989-12-29ANAFRANIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11809bcb4-5fcc-45ca-986a-4fa5edcd4b5e (view SPL)ClomiPRAMINE Hydrochloride Capsules USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-09-251680840790, 680840818
229ec40d4-3d15-436f-b15f-f940ce454d5b (view SPL)Clomipramine Hydrochloride Capsules USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-08-222681513048
332f05aed-18b6-4269-b10c-5d10f5bf7ca2 (view SPL)ClomiPRAMINE Hydrochloride Capsules USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-124636294123
433c772f8-08f0-4f99-8fbd-4de48ad82d89 (view SPL)ClomiPRAMINEHydrochlorideCapsules USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-062548684023
53823106e-6be3-4154-a607-caa3a69dc75c (view SPL)ClomiPRAMINEHydrochloride Capsules, USPprescriptionHuman PrescriptionSandoz Inc2014-09-0815007812027, 007812037, 007812047
63c67bab7-783a-4943-944e-938395b1c3cb (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2007-06-141430630257
74074b555-7635-41a9-809d-fae3b3610059 (view SPL)Anafranil (clomipramine hydrochloride) Capsules USP (25 mg, 50 mg, and 75 mg) Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.MANUFACTURE2014-06-3011004069906, 004069907, 004069908
84c32971e-feb3-4388-9cd6-d1f99f258b0d (view SPL)Clomipramine Hydrochloride Capsules USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.REPACK2015-07-083604290287, 604290288
95af7ec26-5666-41a9-a0a9-1c3b09f6638e (view SPL)Clomipramine Hydrochloride Capsules USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.REPACK2015-07-093604290289
1075347df1-105c-45a2-9c4d-36f3340feac6 (view SPL)ClomiPRAMINE Hydrochloride Capsules USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2011-08-291006157591
117ffd89f1-43ae-4092-8575-d404311da716 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-08-297003783025, 003783050, 003783075
12d0ffac35-c1b3-4f2d-8f11-c99b37e9cca3 (view SPL)ClomiPRAMINEHydrochlorideCapsules USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231001636292756
13d7cee3fa-d05c-4702-8f75-f446627bdb49 (view SPL)Clomipramine Hydrochloride Capsules USP (25 mg, 50 mg, and 75 mg) Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.2015-01-012004068806, 004068807, 004068808
14db752dbd-be41-4cdd-8a13-ed1ff9ef7461 (view SPL)Clomipramine Hydrochloride Capsules USPprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-08-134516724011, 516724012, 516724013

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