FDA.reportPublic FDA data

Application 090576

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIZATIDINENIZATIDINESOLUTION;ORAL15MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301Nizatidine SolutionNizatidineGemini Laboratories, LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
60846-301NIZATIDINENIZATIDINEAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent
65162-659NizatidineNizatidineAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18537ORIG2010-08-27
9279ORIG2009-11-20