FDA.reportPublic FDA data

Application 075191

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTOXIFYLLINEPENTOXIFYLLINETABLET, EXTENDED RELEASE;ORAL400MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8305PENTOXIFYLLINEPENTOXIFYLLINENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8305PENTOXIFYLLINEPENTOXIFYLLINENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0904-5448PENTOXIFYLLINEPENTOXIFYLLINEMajor PharmaceuticalsANDACurrent
0904-5448PENTOXIFYLLINEPENTOXIFYLLINEMajor PharmaceuticalsANDACurrent
33261-992PENTOXIFYLLINEPENTOXIFYLLINEAidarex Pharmaceuticals LLCANDACurrent
53808-0516PentoxifyllinePentoxifyllineState of Florida DOH Central PharmacyANDACurrent
60429-703PENTOXIFYLLINEPENTOXIFYLLINEGolden State Medical Supply, Inc.ANDACurrent
60429-703PENTOXIFYLLINEPENTOXIFYLLINEGolden State Medical Supply, Inc.ANDACurrent
60505-0033PENTOXIFYLLINEPENTOXIFYLLINEApotex Corp.ANDACurrent
60505-0033PENTOXIFYLLINEPENTOXIFYLLINEApotex Corp.ANDACurrent
60505-0033PENTOXIFYLLINEPENTOXIFYLLINEApotex Corp.ANDACurrent
63629-2910PENTOXIFYLLINEPENTOXIFYLLINEBryant Ranch PrepackANDACurrent
63629-2910PENTOXIFYLLINEPENTOXIFYLLINEBryant Ranch PrepackANDACurrent
66267-710PENTOXIFYLLINEPENTOXIFYLLINENuCare Pharmaceuticals, Inc.ANDACurrent
66267-710PENTOXIFYLLINEPENTOXIFYLLINENuCare Pharmaceuticals, Inc.ANDACurrent
67544-252PENTOXIFYLLINEPENTOXIFYLLINEAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9742PENTOXIFYLLINEPENTOXIFYLLINEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1285PENTOXIFYLLINEPENTOXIFYLLINEREMEDYREPACK INC.ANDACurrent
70518-1285PENTOXIFYLLINEPENTOXIFYLLINEREMEDYREPACK INC.ANDACurrent
70518-1285PENTOXIFYLLINEPENTOXIFYLLINEREMEDYREPACK INC.ANDACurrent
70518-1285PENTOXIFYLLINEPENTOXIFYLLINEREMEDYREPACK INC.ANDACurrent
70518-1285PENTOXIFYLLINEPENTOXIFYLLINEREMEDYREPACK INC.ANDACurrent
72189-025PENTOXIFYLLINEPENTOXIFYLLINEDirect_RxANDACurrent
72189-025PENTOXIFYLLINEPENTOXIFYLLINEDirect_RxANDACurrent
72189-025PENTOXIFYLLINEPENTOXIFYLLINEDirect_RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30791ORIG1999-06-09