FDA.reportPublic FDA data

Application 202659

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 25MG BASENoNo
002SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 50MG BASENoNo
003SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-709SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
31722-710SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
31722-711SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
31722-965SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
31722-966SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
31722-967SildenafilSildenafilCamber Pharmaceuticals, Inc.ANDACurrent
50090-5235SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-5325SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-5325SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-5415SildenafilSildenafilA-S Medication SolutionsANDACurrent
50436-0710SildenafilSildenafilUnit Dose ServicesANDACurrent
50436-0710SildenafilSildenafilUnit Dose ServicesANDACurrent
50436-0711SildenafilSildenafilUnit Dose ServicesANDACurrent
61919-755SILDENAFILSILDENAFILDIRECT RXANDACurrent
61919-755SILDENAFILSILDENAFILDIRECT RXANDACurrent
61919-755SILDENAFILSILDENAFILDIRECT RXANDACurrent
61919-755SILDENAFILSILDENAFILDIRECT RXANDACurrent
68071-2552SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2689SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4599SildenafilSildenafilNuCare Pharmaceuticals,InANDACurrent
68071-4599SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4599SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4599SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4599SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4617SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4617SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4674SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4674SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4674SildenafilSildenafilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7879SildenafilSildenafilPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7879SildenafilSildenafilPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1844SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1844SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1844SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1844SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-2128SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-2128SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-2128SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-2128SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-2128SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70934-472SildenafilSildenafilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-472SildenafilSildenafilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-498SildenafilSildenafilProficient Rx LPANDACurrent
71205-498SildenafilSildenafilProficient Rx LPANDACurrent
71205-498SildenafilSildenafilProficient Rx LPANDACurrent
71205-542SildenafilSildenafilProficient Rx LPANDACurrent
71205-542SildenafilSildenafilProficient Rx LPANDACurrent
71335-1028SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1028SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1028SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1028SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1088SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1088SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-1088SildenafilSildenafilBryant Ranch PrepackANDACurrent
72189-069SILDENAFILSILDENAFILDIRECT RXANDACurrent
72189-069SILDENAFILSILDENAFILDIRECT RXANDACurrent
72789-098SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-098SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-098SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-098SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-103SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-103SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-103SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
72865-101SildenafilSildenafilXLCARE Pharmaceuticals INC.ANDACurrent
72865-102SildenafilSildenafilXLCARE Pharmaceuticals INC.ANDACurrent
72865-103SildenafilSildenafilXLCARE Pharmaceuticals INC.ANDACurrent
76519-1216SILDENAFILSILDENAFILH.J. Harkins Company, Inc.ANDACurrent
76519-1218SILDENAFILSILDENAFILH.J. Harkins Company, Inc.ANDACurrent