FDA.reportPublic FDA data

Application 040124

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOLCARISOPRODOLTABLET;ORAL350MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1176CarisoprodolCarisoprodolWest-Ward Pharmaceuticals CorpANDACurrent
0143-1176CarisoprodolCarisoprodolHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1176CarisoprodolCarisoprodolHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1176CarisoprodolCarisoprodolHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9749CarisoprodolCarisoprodolWest-ward Pharmaceutical CorpANDACurrent
10544-132CarisoprodolCarisoprodolBlenheim Pharmacal, Inc.ANDACurrent
33261-387CarisoprodolCarisoprodolAidarex Pharmaceuticals LLCANDACurrent
52959-026CarisoprodolCarisoprodolH.J. Harkins Company, Inc.ANDACurrent
68387-600CarisoprodolCarisoprodolKeltman Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29892SUPPL2008-01-09