FDA.reportPublic FDA data

Application 202573

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RITONAVIRRITONAVIRTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0407RitonavirRitonavirWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0407RitonavirRitonavirWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0407RitonavirRitonavirWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0407RitonavirRitonavirWest-Ward PharmaceuticalsANDACurrent
0054-0407RitonavirRitonavirWest-Ward Pharmaceuticals Corp.ANDACurrent
60687-364RitonavirRitonavirAmerican Health PackagingANDACurrent
69097-655Ritonavirritonavir 100 mgCipla USA Inc.ANDACurrent
70518-1086RitonavirRitonavirREMEDYREPACK INC.ANDACurrent
70518-1086RitonavirRitonavirREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19362ORIG2015-02-17
10081ORIG2015-01-16