Basic Information
Memantine and Donepezil Hydrochlorides Extended-release
69238-1553
Regulatory Information
69238-1553
ANDA208328
C73584
October 5, 2016
USA
These highlights do not include all the information needed to use MEMANTINE and DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE and DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE CAPSULES. MEMANTINE and DONEPEZIL HYDROCHLORIDES extended-release capsules, for oral use Initial U.S. Approval: 2014
HUMAN PRESCRIPTION DRUG LABEL
15
Company Information
123797875
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Code: 2165RE0K14
Class Code: IACT
ETHYLCELLULOSES
Code: 7Z8S9VYZ4B
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
SUCROSE
Code: C151H8M554
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
GELATIN
Code: 2G86QN327L
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
Active Moieties
MEMANTINE
Code: W8O17SJF3T
DONEPEZIL
Code: 8SSC91326P