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USFDA APPLICATION NUMBER - 21615 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - EQ 8MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| GALANTAMINE HYDROBROMIDE(UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA) | GALANTAMINE | 24mg | 16mg | 8mg |
Inactive Ingredients
| Ingredient Name | Mylan Pharmaceuticals Inc. | Teva Pharmaceuticals USA, Inc. | Global Pharmaceuticals, Division of Impax Laboratories Inc. | Bryant Ranch Prepack | Sun Pharmaceutical Industries, Inc. | Actavis Pharma, Inc. |
|---|---|---|---|---|---|---|
| AMMONIA(5138Q19F1X) | ||||||
| D&C RED NO. 30(2S42T2808B) | ||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||
| DIBUTYL SEBACATE(4W5IH7FLNY) | ||||||
| DIETHYL PHTHALATE(UF064M00AF) | ||||||
| ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | ||||||
| ETHYLCELLULOSE(7Z8S9VYZ4B) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| 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 (1600000 WAMW)(RFW2ET671P) | ||||||
| HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU) | ||||||
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | ||||||
| HYPROMELLOSE 2910 (5 CPS)(R75537T0T4) | ||||||
| HYPROMELLOSE 2910 (6 CPS)(0WZ8WG20P6) | ||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||
| INDIGOTINDISULFONATE SODIUM(D3741U8K7L) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| MANNITOL(3OWL53L36A) | ||||||
| POLYETHYLENE GLYCOL 400(B697894SGQ) | ||||||
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | ||||||
| POLYSORBATE 80(6OZP39ZG8H) | ||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
| RAW SUGAR(8M707QY5GH) | ||||||
| SHELLAC(46N107B71O) | ||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||||||
| SODIUM STEARYL FUMARATE(7CV7WJK4UI) | ||||||
| STARCH, CORN(O8232NY3SJ) | ||||||
| SUCROSE(C151H8M554) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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