FDA.reportPublic FDA data

Application 209734

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDEACETAZOLAMIDETABLET;ORAL125MGNoNo
002ACETAZOLAMIDEACETAZOLAMIDETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4511AcetazolamideAcetazolamideA-S Medication SolutionsANDACurrent
50090-4511AcetazolamideAcetazolamideA-S Medication SolutionsANDACurrent
50090-5593AcetazolamideAcetazolamideA-S Medication SolutionsANDACurrent
50268-054AcetazolamideAcetazolamideAvPAKANDACurrent
50268-054AcetazolamideAcetazolamideAvPAKANDACurrent
64380-833AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
64380-833AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
64380-833AcetazolamideAcetazolamideStrides Shasun LimitedANDACurrent
64380-833AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
64380-834AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
64380-834AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
64380-834AcetazolamideAcetazolamideStrides Shasun LimitedANDACurrent
64380-834AcetazolamideAcetazolamideStrides Pharma Science LimitedANDACurrent
71205-308AcetazolamideAcetazolamideProficient Rx LPANDACurrent
71335-1370AcetazolamideAcetazolamideBryant Ranch PrepackANDACurrent
71335-1370AcetazolamideAcetazolamideBryant Ranch PrepackANDACurrent
72789-045AcetazolamideAcetazolamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-045AcetazolamideAcetazolamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-045AcetazolamideAcetazolamidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-045AcetazolamideAcetazolamidePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50502ORIG2017-11-27