FDA.reportPublic FDA data

Application 201384

Type
ANDA
Sponsor
SUN PHARM

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
35356-790TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-790TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-790TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
45865-876TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEmedsource pharmaceuticalsANDACurrent
45865-900TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEmedsource pharmaceuticalsANDACurrent
47335-859TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-859TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-859TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-859TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-859TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-860TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-860TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-860TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-860TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-860TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-861TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-861TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-861TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-861TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
47335-861TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
50090-2215TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-6033TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEA-S Medication SolutionsANDACurrent
55700-016TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-016TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-016TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-029TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-029TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-029TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products LLCANDACurrent
61919-892TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRXANDACurrent
61919-892TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRXANDACurrent
61919-892TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRXANDACurrent
61919-892TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
61919-893TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXANDACurrent
63187-597TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPANDACurrent
63187-597TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPANDACurrent
63187-597TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPANDACurrent
63629-8324TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-8324TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-8324TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
68071-2648TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2732TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68788-7373TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred PharmaceuticalsANDACurrent
68788-7762TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7762TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7762TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7763TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7763TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7763TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8921TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.ANDACurrent
68788-9232TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred PharmaceuticalsANDACurrent
68788-9237TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEPreferred PharmaceuticalsANDACurrent
70518-3386TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3397TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3418TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
71205-656TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPANDACurrent
71205-708TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEProficient Rx LPANDACurrent
71335-1675TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1675TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1675TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1676TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1676TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1676TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch PrepackANDACurrent
76420-244TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76420-245TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76420-246TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEAsclemed USA, Inc.ANDACurrent
76519-1132TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEH. J. Harkins Company Inc.ANDACurrent
76519-1142TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent
80425-0141UltramTramadol 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0141UltramTramadol 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0141Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0141Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0141Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76067ORIG 2023-11-02