FDA.reportPublic FDA data

Application 211893

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
002RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDECAPSULE;ORALEQ 300MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-766Ranitidine HydrochlorideRanitidine HydrochlorideAvKARE, IncANDACurrent
42291-767Ranitidine HydrochlorideRanitidine HydrochlorideAvKARE, IncANDACurrent
62559-690Ranitidine HydrochlorideRanitidine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-690Ranitidine HydrochlorideRanitidine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-691Ranitidine HydrochlorideRanitidine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-691Ranitidine HydrochlorideRanitidine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent