FDA.reportPublic FDA data

Application 200482

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 5MG BASENoNo
002RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-825Rizatriptan BenzoateRizatriptan BenzoateMedsource PharmaceuticalsANDACurrent
45865-825Rizatriptan BenzoateRizatriptan BenzoateMedsource PharmaceuticalsANDACurrent
50090-3921Rizatriptan BenzoateRizatriptan BenzoateA-S Medication SolutionsANDACurrent
50090-3921Rizatriptan BenzoateRizatriptan BenzoateA-S Medication SolutionsANDACurrent
50090-3921Rizatriptan BenzoateRizatriptan BenzoateA-S Medication SolutionsANDACurrent
51991-354Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-354Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-354Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-354Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-354Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-355Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-355Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-355Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-355Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-355Rizatriptan BenzoateRizatriptan BenzoateBreckenridge Pharmaceutical, Inc.ANDACurrent