FDA.reportPublic FDA data

Application 205257

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGNoNo
003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4152Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4152Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4152Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4152Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4152Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4153Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4153Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4153Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4153Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4153Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4154Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4154Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4154Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4154Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4154Tramadol Hydrochloridetramadol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
68788-7284Tramadol Hydrochloridetramadol hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76124ORIG 2023-11-03