FDA.reportPublic FDA data

Application 075977

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0058Tramadol HydrochlorideTramadol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
60429-588Tramadol HydrochlorideTramadol HydrochlorideGSMS, IncorporatedANDACurrent
60429-588Tramadol HydrochlorideTramadol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-588Tramadol HydrochlorideTramadol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-588Tramadol HydrochlorideTramadol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-588Tramadol HydrochlorideTramadol HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
70518-3598Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
71610-006Tramadol HydrochlorideTramadol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-006Tramadol HydrochlorideTramadol HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76141ORIG 2023-11-03
22524ORIG2008-08-01
31055ORIG2002-06-19
18434ORIG2002-06-19