FDA.reportPublic FDA data

Application 078380

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILDENAFIL CITRATESILDENAFIL CITRATETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5517SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5517SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5517SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5517SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5517SildenafilSildenafilTeva Pharmaceuticals USA, Inc.ANDACurrent
43063-668SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-668SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-668SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-668SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-668SildenafilSildenafilPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2618SildenafilSildenafilA-S Medication SolutionsANDACurrent
50090-2618SildenafilSildenafilA-S Medication SolutionsANDACurrent
50436-5517SildenafilSildenafilUnit Dose ServicesANDACurrent
53002-1719SildenafilSildenafilRPK Pharmaceuticals, Inc.ANDACurrent
53002-1719SildenafilSildenafilRPK Pharmaceuticals, Inc.ANDACurrent
68071-3137SildenafilSildenafilNuCare Pharmaceuticals, Inc.ANDACurrent
70934-208SildenafilSildenafilDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-509SildenafilSildenafilProficient Rx LPANDACurrent
71335-0288SildenafilSildenafilBryant Ranch PrepackANDACurrent
71335-0288SildenafilSildenafilBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9152ORIG2007-08-14