FDA.reportPublic FDA data

Application 076183

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 24MG BASENoNo
002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 8MG BASENoNo
003ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
004ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 16MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8185ondansetron hydrochlorideondansetron hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8185ondansetron hydrochlorideondansetron hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8185ondansetron hydrochlorideondansetron hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6551ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6551ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6551ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6551ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6552ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6552ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6552ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6552ondansetron hydrochlorideondansetron hydrochlorideMajor PharmaceuticalsANDACurrent
51662-1539ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55111-153ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-153ondansetron hydrochlorideondansetron hydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-153ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-153ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-154ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-154ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-154ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-154ondansetron hydrochlorideondansetron hydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55111-155ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-155ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-156ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-156ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-156ondansetron hydrochlorideondansetron hydrochlorideDr. Reddy's Laboratories LimitedANDACurrent
55111-156ondansetron hydrochlorideondansetron hydrochlorideDr.Reddy's Laboratories LimitedANDACurrent
55154-7879ondansetron hydrochlorideondansetron hydrochlorideCardinal HealthANDACurrent
70518-1042ondansetron hydrochlorideondansetron hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1042ondansetron hydrochlorideondansetron hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8874ORIG2007-01-08