FDA.reportPublic FDA data

Application 077184

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDETABLET;ORAL325MG;37.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3705TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENA-S Medication SolutionsANDACurrent
50090-3705TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENA-S Medication SolutionsANDACurrent
52959-814TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENH.J. Harkins Company, Inc.ANDACurrent
57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
57664-537TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENSun Pharmaceutical Industries, Inc.ANDACurrent
68071-2831TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.ANDACurrent
68084-825Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmerican Health PackagingANDACurrent
68084-825Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmerican Health PackagingANDACurrent
68084-825Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmerican Health PackagingANDACurrent
68084-825Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and AcetaminophenAmerican Health PackagingANDACurrent
68788-9261TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENPreferred PharmaceuticalsANDACurrent
71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent
71335-0151TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76085ORIG 2023-11-02