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USFDA APPLICATION NUMBER - 204736 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 5MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| RABEPRAZOLE SODIUM(UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL) | RABEPRAZOLE SODIUM | 10mg | 5mg |
Inactive Ingredients
| Ingredient Name | Avadel Pharmaceuticals (USA), Inc. | Aytu Therapeutics, LLC |
|---|---|---|
| ALUMINUM OXIDE(LMI26O6933) | ||
| CARRAGEENAN(5C69YCD2YJ) | ||
| DIACETYLATED MONOGLYCERIDES(5Z17386USF) | ||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | ||
| HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | ||
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR) | ||
| MAGNESIUM OXIDE(3A3U0GI71G) | ||
| MAGNESIUM STEARATE(70097M6I30) | ||
| MANNITOL(3OWL53L36A) | ||
| POTASSIUM CHLORIDE(660YQ98I10) | ||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||
| TALC(7SEV7J4R1U) | ||
| TITANIUM DIOXIDE(15FIX9V2JP) |
