Application 090618

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NIZATIDINENIZATIDINECAPSULE;ORAL150MGNoNo
002NIZATIDINENIZATIDINECAPSULE;ORAL300MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-374NizatidineNizatidineMedsource PharmaceuticalsANDACurrent
63187-249NizatidineNizatidineProficient Rx LPANDACurrent
63187-249NizatidineNizatidineProficient Rx LPANDACurrent
68071-1633NizatidineNizatidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1633NizatidineNizatidineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1633NizatidineNizatidineNuCare Pharmaceuticals,Inc.ANDACurrent
68462-425NizatidineNizatidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-425NizatidineNizatidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-426NizatidineNizatidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-426NizatidineNizatidineGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-8913NizatidineNizatidinePreferred Pharmaceuticals Inc.ANDACurrent
71335-0086NizatidineNizatidineBryant Ranch PrepackANDACurrent
71335-0086NizatidineNizatidineBryant Ranch PrepackANDACurrent