FDA.reportPublic FDA data

Application 091649

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPECITABINECAPECITABINETABLET;ORAL150MGNoNo
002CAPECITABINECAPECITABINETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7473CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7473CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7473CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7473CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7474CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7474CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7474CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7474CapecitabineCapecitabineTeva Pharmaceuticals USA, Inc.ANDACurrent
51407-639CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
51407-640CapecitabineCapecitabineGolden State Medical Supply, Inc.ANDACurrent
60687-149CapecitabineCapecitabineAmerican Health PackagingANDACurrent
60687-149CapecitabineCapecitabineAmerican Health PackagingANDACurrent
60687-149CapecitabineCapecitabineAmerican Health PackagingANDACurrent
60687-149CapecitabineCapecitabineAmerican Health PackagingANDACurrent
60687-149CapecitabineCapecitabineAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18544ORIG2013-09-19
9349ORIG2013-09-19