FDA.reportPublic FDA data

Application 200491

Type
ANDA
Sponsor
ANCHEN PHARMS

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
10370-221Tramadol Hydrochloridetramadol hydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-221Tramadol Hydrochloridetramadol hydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-221Tramadol Hydrochloridetramadol hydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-222Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-222Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-222Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-223Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-223Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-223Tramadol HydrochlorideTramadol HydrochloridePar Pharmaceutical, Inc.ANDACurrent
60429-583Tramadol Hydrochloridetramadol hydrochloride extended-release tabletsGolden State Medical Supply, Inc.ANDACurrent
60429-583Tramadol Hydrochloridetramadol hydrochloride extended-release tabletsGolden State Medical Supply, Inc.ANDACurrent
60429-583Tramadol Hydrochloridetramadol hydrochloride extended-release tabletsGolden State Medical Supply, Inc.ANDACurrent
60429-584Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
60429-584Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
60429-584Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
60429-585Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
60429-585Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
60429-585Tramadol HydrochlorideTramadol Hydrochloride Extended-Release TabletsGolden State Medical Supply, Inc.ANDACurrent
70518-2005Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2005Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2005Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2005Tramadol HydrochlorideTramadol HydrochlorideREMEDYREPACK INC.ANDACurrent
80425-0101ConzipTramadol HCl 200mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0101Tramadol HCLTramadol HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76322ORIG 2023-11-03