USFDA APPLICATION NUMBER - 21416 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
PROPAFENONE HYDROCHLORIDE(UNII: 33XCH0HOCD) (PROPAFENONE - UNII:68IQX3T69U) | PROPAFENONE HYDROCHLORIDE | 425mg | 325mg | 225mg |
Inactive Ingredients
Ingredient Name | American Health Packaging | AvKARE, Inc. | Golden State Medical Supply, Inc. | Mylan Pharmaceuticals Inc. | Proficient Rx LP | TWi Pharmaceuticals, Inc. | Wilshire Pharmaceuticals | Golden State Medical Supply | Cadila Healthcare Limited | Zydus Pharmaceuticals (USA) Inc. | Prasco Laboratories | Actavis Pharma, Inc. | Glenmark Pharmaceuticals Inc., USA |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ALCOHOL(3K9958V90M) | |||||||||||||
Ammonia(5138Q19F1X) | |||||||||||||
ANHYDROUS LACTOSE(3SY5LH9PMK) | |||||||||||||
BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
D&C YELLOW NO. 10(35SW5USQ3G) | |||||||||||||
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. 3(PN2ZH5LOQY) | |||||||||||||
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) | |||||||||||||
HYPROMELLOSE 2910 (10000 MPA.S)(0HO1H52958) | |||||||||||||
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |||||||||||||
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | |||||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||
LECITHIN, SOYBEAN(1DI56QDM62) | |||||||||||||
Magnesium Stearate(70097M6I30) | |||||||||||||
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |||||||||||||
POTASSIUM HYDROXIDE(WZH3C48M4T) | |||||||||||||
POVIDONE(FZ989GH94E) | |||||||||||||
POVIDONE, UNSPECIFIED(FZ989GH94E) | |||||||||||||
PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
SHELLAC(46N107B71O) | |||||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
TALC(7SEV7J4R1U) | |||||||||||||
TITANIUM DIOXIDE(15FIX9V2JP) | |||||||||||||
WATER(059QF0KO0R) |
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