USFDA APPLICATION NUMBER - 22525 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 21MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
MEMANTINE HYDROCHLORIDE(UNII: JY0WD0UA60) (memantine - UNII:W8O17SJF3T) | MEMANTINE HYDROCHLORIDE | 7mg |
Inactive Ingredients
Ingredient Name | Apotex Corp | Avera McKennan Hospital | Mylan Pharmaceuticals Inc. | NorthStar RxLLC | Golden State Medical Supply, Inc. | Lupin Pharmaceuticals, Inc. | Major Pharmaceuticals | Par Pharmaceutical, Inc. | Bryant Ranch Prepack | NCS HealthCare of KY, Inc dba Vangard Labs |
---|---|---|---|---|---|---|---|---|---|---|
AMMONIA(5138Q19F1X) | ||||||||||
BUTYL ALCOHOL(8PJ61P6TS3) | ||||||||||
D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||||
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV) | ||||||||||
ETHYLCELLULOSE (7 MPA.S)(H3UP11403C) | ||||||||||
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||||
ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||||
FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||||
FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||||
FD&C GREEN NO. 3(3P3ONR6O1S) | ||||||||||
FD&C RED NO. 40(WZB9127XOA) | ||||||||||
FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||||
FERRIC OXIDE RED(1K09F3G675) | ||||||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||||
FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||||
GELATIN(2G86QN327L) | ||||||||||
GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||||
HYDROXYPROPYL CELLULOSE (70000 WAMW)(66O7AQV0RT) | ||||||||||
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F) | ||||||||||
HYDROXYPROPYL CELLULOSE (TYPE E)(66O7AQV0RT) | ||||||||||
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | ||||||||||
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W) | ||||||||||
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||||
HYPROMELLOSES(3NXW29V3WO) | ||||||||||
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U) | ||||||||||
METHYLCELLULOSE (15 MPA.S)(NPU9M2E6L8) | ||||||||||
OLEIC ACID(2UMI9U37CP) | ||||||||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||||||
POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||||||
POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||||
POLYSORBATE 80(6OZP39ZG8H) | ||||||||||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | ||||||||||
POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||||
povidone K30(U725QWY32X) | ||||||||||
PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||||
SHELLAC(46N107B71O) | ||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | ||||||||||
STARCH, CORN(O8232NY3SJ) | ||||||||||
sucrose(C151H8M554) | ||||||||||
TALC(7SEV7J4R1U) | ||||||||||
TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||||
TRIETHYL CITRATE(8Z96QXD6UM) |
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