FDA.reportPublic FDA data

Application 074352

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDESOLUTION;ORAL1MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0618Loperamide HydrochlorideLoperamide HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-0618Loperamide HydrochlorideLoperamide HydrochlorideAtlantic Biologicals CorpsANDACurrent
50090-0461Loperamide HydrochlorideLoperamide HydrochlorideA-S Medication SolutionsANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-618Loperamide HydrochlorideLoperamide HydrochlorideAkornANDACurrent
68151-0618Loperamide HydrochlorideLoperamide HydrochlorideCarilion Materials ManagementANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9773Loperamide HydrochlorideLoperamide HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent