FDA.reportPublic FDA data

Application 077342

Type
ANDA
Sponsor
TEVA

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
0093-5341SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5341SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5341SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5342SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5342SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5342SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5343SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5343SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5343SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-746SildenafilSildenafilAvKAREANDACurrent
42291-746SildenafilSildenafilAvKAREANDACurrent
42291-746SildenafilSildenafilAvKARE, Inc.ANDACurrent
42291-747SildenafilSildenafilAvKARE, Inc.ANDACurrent
42291-747SildenafilSildenafilAvKAREANDACurrent
42291-747SildenafilSildenafilAvKAREANDACurrent
42291-748SildenafilSildenafilAvKARE, Inc.ANDACurrent
42291-748SildenafilSildenafilAvKAREANDACurrent
42291-748SildenafilSildenafilAvKAREANDACurrent
50090-5039SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-5039SildenafilSildenafilA-S Medication SolutionsANDACurrent
55700-706SildenafilSildenafilQuality Care Products, LLCANDACurrent
70518-1216SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1216SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1216SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
70518-1216SildenafilSildenafilREMEDYREPACK INC.ANDACurrent
71205-088SildenafilSildenafilProficient Rx LPANDACurrent
71205-088SildenafilSildenafilProficient Rx LPANDACurrent
71205-088SildenafilSildenafilProficient Rx LPANDACurrent
71205-088SildenafilSildenafilProficient Rx LPANDACurrent
71205-267SildenafilSildenafilProficient Rx LPANDACurrent
71205-267SildenafilSildenafilProficient Rx LPANDACurrent
71205-267SildenafilSildenafilProficient Rx LPANDACurrent
71335-1777SildenafilSildenafilBryant Ranch PrepackANDACurrent
71610-237SildenafilSildenafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-237SildenafilSildenafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-256SildenafilSildenafilAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-271SildenafilSildenafilAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50339ORIG2017-11-08