FDA.reportPublic FDA data

Application 019906

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANAFRANILCLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL25MGYesYes
002ANAFRANILCLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL50MGYesNo
003ANAFRANILCLOMIPRAMINE HYDROCHLORIDECAPSULE;ORAL75MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-8806CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-8806CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-8807CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-8807CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-8808CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-8808CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9906ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9906ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9906ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9907ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9907ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9907ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9908ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9908ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent
0406-9908ANAFRANILclomipramine hydrochlorideSpecGx LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58694SUPPL2019-05-14
58671SUPPL2019-05-14
58668SUPPL2019-05-14
55322SUPPL2018-08-27
48546SUPPL2017-05-26
48533SUPPL2017-05-25
19827SUPPL2014-07-29
11838SUPPL2014-07-29
11837SUPPL2014-07-11
1800SUPPL2014-07-11
1799SUPPL2012-10-29
11836SUPPL2012-10-26
19826SUPPL2007-07-24
11835SUPPL2007-07-16
41091SUPPL2007-06-12
23559ORIG2007-05-09
11834SUPPL2005-01-13
1798SUPPL2005-01-13
19825SUPPL2004-09-07
34087SUPPL2003-06-10