FDA.reportPublic FDA data

Application 040621

Type
ANDA
Sponsor
SUN PHARM INDS (IN)

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUMCAPSULE;ORAL100MG EXTENDEDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2903PHENYTOIN SODIUMPHENYTOIN SODIUMA-S Medication SolutionsANDACurrent
53002-1501PHENYTOIN SODIUMPHENYTOIN SODIUMRPK Pharmaceuticals, Inc.ANDACurrent
53002-1501PHENYTOIN SODIUMPHENYTOIN SODIUMRPK Pharmaceuticals, Inc.ANDACurrent
58118-1402PHENYTOIN SODIUMPHENYTOIN SODIUMClinical Solutions WholesaleANDACurrent
58118-1402PHENYTOIN SODIUMPHENYTOIN SODIUMClinical Solutions WholesaleANDACurrent
62756-402PHENYTOIN SODIUMPHENYTOIN SODIUMSun Pharmaceutical Industries, Inc.ANDACurrent
63187-891PHENYTOIN SODIUMPHENYTOIN SODIUMProficient Rx LPANDACurrent
63187-891PHENYTOIN SODIUMPHENYTOIN SODIUMProficient Rx LPANDACurrent
63629-6364PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent
63629-6364PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent
63629-6382PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent
63629-6382PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent
67296-1251PHENYTOIN SODIUMPHENYTOIN SODIUMRedPharm Drug, Inc.ANDACurrent
67296-1251PHENYTOIN SODIUMPHENYTOIN SODIUMRedPharm Drug, Inc.ANDACurrent
70518-0981PHENYTOIN SODIUMPHENYTOIN SODIUMREMEDYREPACK INC.ANDACurrent
70518-0981PHENYTOIN SODIUMPHENYTOIN SODIUMREMEDYREPACK INC.ANDACurrent
71335-0232PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent
71335-0232PHENYTOIN SODIUMPHENYTOIN SODIUMBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42634ORIG2006-12-11