FDA.reportPublic FDA data

Application 204234

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53217-224DOXYCYCLINEDOXYCYCLINEAidarex Pharmaceuticals LLCANDACurrent
63187-672DOXYCYCLINEDOXYCYCLINEProficient Rx LPANDACurrent
63187-672DOXYCYCLINEDOXYCYCLINEProficient Rx LPANDACurrent
63629-6853DOXYCYCLINEDOXYCYCLINEBryant Ranch PrepackANDACurrent
63629-6853DOXYCYCLINEDOXYCYCLINEBryant Ranch PrepackANDACurrent
63629-6927DOXYCYCLINEDOXYCYCLINEBryant Ranch PrepackANDACurrent
63629-6927DOXYCYCLINEDOXYCYCLINEBryant Ranch PrepackANDACurrent
67296-1368DOXYCYCLINEDOXYCYCLINERedPharm Drug, Inc.ANDACurrent
67296-1368DOXYCYCLINEDOXYCYCLINERedPharm Drug, Inc.ANDACurrent
67296-1368DOXYCYCLINEDOXYCYCLINERedPharm Drug, Inc.ANDACurrent
68180-650DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-650DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-650DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-650DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-651DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-651DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-651DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-651DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-652DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-652DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-652DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
68180-652DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.ANDACurrent
69482-450OkebodoxycyclineEncore Dermatology Inc.ANDACurrent
69482-450OkebodoxycyclineEncore Dermatology Inc.ANDACurrent
69482-475OkebodoxycyclineEncore Dermatology Inc.ANDACurrent
69482-475OkebodoxycyclineEncore Dermatology Inc.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-0213DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-3365DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent
70518-3365DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.ANDACurrent