FDA.reportPublic FDA data

Application 075964

Type
ANDA
Sponsor
SUN PHARM INDS INC

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
0904-7179tramadol hydrochloridetramadol hydrochlorideMajor PharmaceuticalsANDACurrent
16714-481tramadol hydrochloridetramadol hydrochlorideNorthstar Rx LLCANDACurrent
16714-481tramadol hydrochloridetramadol hydrochlorideNorthstar Rx LLCANDACurrent
16714-481tramadol hydrochloridetramadol hydrochlorideNorthstar Rx LLCANDACurrent
33261-483tramadol hydrochloridetramadol hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
45865-115tramadol hydrochloridetramadol hydrochlorideMedsource PharmaceuticalsANDACurrent
45865-120tramadol hydrochloridetramadol hydrochlorideMedsource PharmaceuticalsANDACurrent
50090-0806tramadol hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
50090-0806tramadol hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
50090-0807tramadol hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
50090-0807tramadol hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
50090-3501tramadol hydrochloridetramadol hydrochlorideA-S Medication SolutionsANDACurrent
50436-0377tramadol hydrochloridetramadol hydrochlorideUnit Dose ServicesANDACurrent
53002-4322tramadol hydrochloridetramadol hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-864tramadol hydrochloridetramadol hydrochlorideQuality Care Products, LLCANDACurrent
55700-864tramadol hydrochloridetramadol hydrochlorideQuality Care Products, LLCANDACurrent
55700-864tramadol hydrochloridetramadol hydrochlorideQuality Care Products, LLCANDACurrent
55700-864tramadol hydrochloridetramadol hydrochlorideQuality Care Products, LLCANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-377tramadol hydrochloridetramadol hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
58118-0377tramadol hydrochloridetramadol hydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-0377tramadol hydrochloridetramadol hydrochlorideClinical Solutions Wholesale, LLCANDACurrent
60760-377tramadol hydrochloridetramadol hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-377tramadol hydrochloridetramadol hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-377tramadol hydrochloridetramadol hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-377tramadol hydrochloridetramadol hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect RxANDACurrent
61919-229TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirect_RxANDACurrent
63629-4394tramadol hydrochloridetramadol hydrochlorideBryant Ranch PrepackANDACurrent
63629-4394tramadol hydrochloridetramadol hydrochlorideBryant Ranch PrepackANDACurrent
63629-4394tramadol hydrochloridetramadol hydrochlorideBryant Ranch PrepackANDACurrent
63629-8190tramadol hydrochloridetramadol hydrochlorideBryant Ranch PrepackANDACurrent
63629-8190tramadol hydrochloridetramadol hydrochlorideBryant Ranch PrepackANDACurrent
66336-915tramadol hydrochloridetramadol hydrochlorideDispensing Solutions, Inc.ANDACurrent
67046-729tramadol hydrochloridetramadol hydrochlorideContract Pharmacy Services-PAANDACurrent
67296-1021tramadol hydrochloridetramadol hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1021tramadol hydrochloridetramadol hydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1021tramadol hydrochloridetramadol hydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-4282tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4282tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4282tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4802tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4802tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4802tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5142tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5142tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5142tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5204tramadol hydrochloridetramadol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7321tramadol hydrochloridetramadol hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7321tramadol hydrochloridetramadol hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7321tramadol hydrochloridetramadol hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7321tramadol hydrochloridetramadol hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0258tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0891tramadol hydrochloridetramadol hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76078ORIG 2023-11-02
31053ORIG2002-06-19
18431ORIG2002-06-19