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USFDA APPLICATION NUMBER - 50686 / DOSAGE - FOR SUSPENSION;ORAL - EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 |
|---|---|---|
| ceftibuten dihydrate(UNII: 62F4443RWP) (CEFTIBUTEN - UNII:IW71N46B4Y) | CEFTIBUTEN | 400mg | 180mg in 5 |
Inactive Ingredients
| Ingredient Name | Macoven Pharmaceuticals | Pernix Therapeutics, LLC |
|---|---|---|
| BENZYL ALCOHOL(LKG8494WBH) | ||
| BUTYLPARABEN(3QPI1U3FV8) | ||
| EDETATE CALCIUM DISODIUM(25IH6R4SGF) | ||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| METHYLPARABEN(A2I8C7HI9T) | ||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||
| POLYSORBATE 80(6OZP39ZG8H) | ||
| PROPYLPARABEN(Z8IX2SC1OH) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| SODIUM BENZOATE(OJ245FE5EU) | ||
| SODIUM LAURYL SULFATE(368GB5141J) | ||
| SODIUM PROPIONATE(DK6Y9P42IN) | ||
| SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2) | ||
| SUCROSE(C151H8M554) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||
| XANTHAN GUM(TTV12P4NEE) |
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