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USFDA APPLICATION NUMBER - 17604 / DOSAGE - CAPSULE;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| FENOPROFEN CALCIUM(UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY) | FENOPROFEN | 400mg |
Inactive Ingredients
| Ingredient Name | BPI Labs LLC | Sterling Knight Pharmaceuticals LLC | Bryant Ranch Prepack | Burke Therapeutics, LLC | Medsource Pharmaceuticals | Preferred Pharmaceuticals, Inc. |
|---|---|---|---|---|---|---|
| BROWN IRON OXIDE(1N032N7MFO) | ||||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||||
| CROSPOVIDONE(2S7830E561) | ||||||
| CROSPOVIDONE(68401960MK) | ||||||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | ||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| GELATIN(2G86QN327L) | ||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| TALC(7SEV7J4R1U) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
