FDA.reportPublic FDA data

Application 019487

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMODIUM A-DLOPERAMIDE HYDROCHLORIDESOLUTION;ORAL1MG/5MLYesYes
002IMODIUM A-DLOPERAMIDE HYDROCHLORIDESUSPENSION;ORAL1MG/7.5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-134ImodiumLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-134ImodiumLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-134ImodiumLoperamide HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59669SUPPL2019-08-13
59668SUPPL2019-08-12
48028SUPPL2017-04-14
48020SUPPL2017-04-14
11512SUPPL2016-04-11
1341SUPPL2016-04-07
11511SUPPL2015-03-24
17418SUPPL2015-03-19
20250SUPPL2008-07-31
40913SUPPL2008-07-30
20249SUPPL2008-04-04
1340SUPPL2005-06-09
1339SUPPL2004-07-14
17417SUPPL2004-06-16