FDA.reportPublic FDA data

Application 087846

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFRANILIMIPRAMINE HYDROCHLORIDETABLET;ORAL50MGNoYes
002IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-9920TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9920TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9920TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9920TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9921TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9921TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9921TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9921TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9922TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9922TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9922TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent
0406-9922TOFRANILimipramine hydrochlorideSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56360SUPPL2018-11-08
18518SUPPL2014-09-05
9247SUPPL2013-03-13
18517SUPPL2013-03-12
44410ORIG2007-05-09