FDA.reportPublic FDA data

Application 090041

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-551Memantine hydrochlorideMemantineAvKARE, Inc.ANDACurrent
42291-552Memantine hydrochlorideMemantineAvKARE, Inc.ANDACurrent
53746-169Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-169Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-169Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-173Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-173Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
53746-173Memantine hydrochlorideMemantineAmneal Pharmaceuticals of New York LLCANDACurrent
65162-169memantine hydrochloridememantineAmneal Pharmaceuticals LLCANDACurrent
65162-173memantine hydrochloridememantineAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31443ORIG2016-02-18