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USFDA APPLICATION NUMBER - 50606 / DOSAGE - CAPSULE;ORAL - EQ 125MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU) | VANCOMYCIN | 125mg | 250mg |
Inactive Ingredients
| Ingredient Name | Orient Pharma Co.,Ltd Yunlin Plant | PAI Holdings, LLC | APP Pharmaceuticals, LLC | Fresenius Kabi USA, LLC | Lupin Pharmaceuticals, Inc. | Prasco Laboratories |
|---|---|---|---|---|---|---|
| CARNAUBA WAX(R12CBM0EIZ) | ||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||
| GELATIN(2G86QN327L) | ||||||
| GLYCERYL MONOOLEATE(C4YAD5F5G6) | ||||||
| POLYETHYLENE GLYCOL 6000(30IQX730WE) | ||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||
| POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | ||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
| SHELLAC(46N107B71O) | ||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||
| TITANIUM DIOXIDE(15FIX9V2JP) |
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