FDA.reportPublic FDA data

Application 079133

Type
ANDA
Sponsor
SIGMAPHARM LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMILORIDE HYDROCHLORIDEAMILORIDE HYDROCHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-122Amiloride HydrochlorideAmiloride HydrochlorideAvKARE, Inc.ANDACurrent
42794-005Amiloride HydrochlorideAmiloride HydrochlorideSigmapharm Laboratories, LLCANDACurrent
42794-005Amiloride HydrochlorideAmiloride HydrochlorideSigmapharm Laboratories, LLCANDACurrent
50268-071Amiloride HydrochlorideAmiloride HydrochlorideAvPAKANDACurrent
64980-151Amiloride HydrochlorideAmiloride HydrochlorideRising Pharmaceuticals, IncANDACurrent