FDA.reportPublic FDA data

Application 018337

Type
NDA
Sponsor
TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENSUPPOSITORY;RECTAL650MGYesYes
002ACETAMINOPHENACETAMINOPHENSUPPOSITORY;RECTAL325MGYesNo
003ACETAMINOPHENACETAMINOPHENSUPPOSITORY;RECTAL120MGYesNo
004INFANTS' FEVERALLACETAMINOPHENSUPPOSITORY;RECTAL80MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51672-2114FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2114FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2115FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2115FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2116FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2116FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
51672-2117FeverallAcetaminophenTaro Pharmaceuticals U.S.A. Inc.NDACurrent
63629-8240FeverallAcetaminophenBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61855SUPPL2020-02-10
61854SUPPL2020-02-10
14987SUPPL2015-08-13
11209SUPPL2015-08-13
11208SUPPL2014-01-28
14986SUPPL2014-01-17
40795SUPPL2012-03-30
14985SUPPL2010-04-08
14984SUPPL2008-07-01
14983SUPPL2007-11-08