FDA.reportPublic FDA data

Application 020603

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S MOTRINIBUPROFENSUSPENSION/DROPS;ORAL40MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50580-100Infants MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-100Infants MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-198MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-198MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-198MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-198MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-198MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47593SUPPL2017-03-20
47575SUPPL2017-03-17
45217SUPPL2016-08-29
45181SUPPL2016-08-29
2852SUPPL2010-07-19
25299SUPPL2009-05-06
25298SUPPL2006-03-01
12823SUPPL2002-01-16
2851SUPPL2002-01-16
34942SUPPL1999-09-13
20758SUPPL1999-09-13
2850SUPPL1999-09-13
20759SUPPL1999-04-15
41472SUPPL1998-06-12
12822SUPPL1998-06-12
2849SUPPL1998-06-12