FDA.reportPublic FDA data

Application 211100

Type
ANDA
Sponsor
YICHANG HUMANWELL

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
70436-054Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-054Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-054Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-055Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-055Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-055Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-056Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-056Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-056Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-057Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-057Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent
70436-057Memantine Hydrochloridememantine hydrochlorideSlate Run Pharmaceuticals, LLCANDACurrent