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USFDA APPLICATION NUMBER - 21416 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425MG
| 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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