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USFDA APPLICATION NUMBER - 50813 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| AMOXICILLIN(UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) | AMOXICILLIN ANHYDROUS | 775mg |
Inactive Ingredients
| Ingredient Name | Shionogi Inc. | Fera Pharmaceuticals, LLC | Pragma Pharmaceuticals, LLC | Vernalis Therapeutics, Inc. |
|---|---|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||||
| cellulose, microcrystalline(OP1R32D61U) | ||||
| CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | ||||
| crospovidone(68401960MK) | ||||
| CROSPOVIDONE, UNSPECIFIED(2S7830E561) | ||||
| FD&C blue no. 2(L06K8R7DQK) | ||||
| ferric oxide red(1K09F3G675) | ||||
| hypromellose acetate succinate 16070722 (3 mm2/s)(24P2YXD2PW) | ||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||
| hypromelloses(3NXW29V3WO) | ||||
| MAGNESIUM STEARATE(70097M6I30) | ||||
| methacrylic acid - methyl methacrylate copolymer (1:1)(74G4R6TH13) | ||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||
| polyethylene glycol 400(B697894SGQ) | ||||
| polyoxyl 35 castor oil(6D4M1DAL6O) | ||||
| povidone(FZ989GH94E) | ||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||
| shellac(46N107B71O) | ||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||
| talc(7SEV7J4R1U) | ||||
| titanium dioxide(15FIX9V2JP) | ||||
| TRIETHYL CITRATE(8Z96QXD6UM) |
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