FDA.reportPublic FDA data

Application 091607

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoYes
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
47335-531TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-531TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-531TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-531TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-531TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-533TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-533TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-533TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-533TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-533TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-537TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-537TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-537TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-537TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-537TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
50436-0824TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEUnit Dose ServicesANDACurrent
50436-8788TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEUnit Dose ServicesANDACurrent
80425-0127ConzipTramadol 200mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0127Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0127Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0127Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76049ORIG 2023-11-02
43253ORIG2012-02-14
31543ORIG2012-02-14