FDA.reportPublic FDA data

Application 205365

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL7MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL14MGNoNo
003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL21MGNoNo
004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL28MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-242Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-242Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-242Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-243Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-243Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-243Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-264Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-264Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-264Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-266Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-266Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
43975-266Memantine HydrochlorideMemantine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
63629-1956Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1956Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1956Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1956Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1957Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1957Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1957Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1957Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1982Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1982Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1982Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1982Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1983Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1983Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1983Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1983Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1984Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1984Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1984Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1984Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1985Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1985Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1985Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1985Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2142Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2142Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2142Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2142Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2143Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2143Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2143Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2143Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
63629-9286Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent