FDA.reportPublic FDA data

Application 207836

Type
ANDA
Sponsor
UNICHEM LABS 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
29300-316Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-316Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-316Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-316Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-317Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-317Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-317Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-317Rizatriptan BenzoateRizatriptan BenzoateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
71335-1172Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1172Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1172Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1172Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1257Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1257Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent
71335-1257Rizatriptan BenzoateRizatriptan BenzoateBryant Ranch PrepackANDACurrent