FDA.reportPublic FDA data

Application 075986

Type
ANDA
Sponsor
MYLAN

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
0378-4151Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4151Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4151Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4151Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4151Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-7810Tramadol Hydrochloridetramadol hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-5094Tramadol Hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
51079-991Tramadol Hydrochloridetramadol hydrochlorideMylan Institutional Inc.ANDACurrent
51079-991Tramadol Hydrochloridetramadol hydrochlorideMylan Institutional Inc.ANDACurrent
51079-991Tramadol Hydrochloridetramadol hydrochlorideMylan Institutional Inc.ANDACurrent
51079-991Tramadol Hydrochloridetramadol hydrochlorideMylan Institutional Inc.ANDACurrent
51079-991Tramadol Hydrochloridetramadol hydrochlorideMylan Institutional Inc.ANDACurrent
53002-4323Tramadol Hydrochloridetramadol hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55154-5656Tramadol HydrochlorideTramadol HydrochlorideCardinal HealthANDACurrent
55154-5656Tramadol HydrochlorideTramadol HydrochlorideCardinal HealthANDACurrent
67296-1766Tramadol Hydrochloridetramadol hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1766Tramadol Hydrochloridetramadol hydrochlorideRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43042ORIG2008-08-01
31056ORIG2002-06-21
18436ORIG2002-06-21