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FDA Product

Memantine and Donepezil Hydrochlorides Extended-release

Product approved by U.S. Food and Drug Administration (US)

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

MEMANTINE HYDROCHLORIDE

Quantity: 21 mg in 1 1

Code: JY0WD0UA60

Class Code: ACTIB

DONEPEZIL HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 3O2T2PJ89D

Class Code: ACTIB

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

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