FDA.reportPublic FDA data

Application 208328

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;14MGNoNo
002MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;28MGNoNo
003MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;7MGNoNo
004MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MG;21MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1247Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1247Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1247Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals LLCANDACurrent
69238-1247Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1247Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1248Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1248Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals LLCANDACurrent
69238-1248Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1248Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1248Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1552Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1552Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1552Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1552Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1553Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1553Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1553Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1553Memantine and Donepezil Hydrochlorides Extended-releaseMemantine and DonepezilAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47076ORIG2017-01-31
47057ORIG2017-01-31