USFDA APPLICATION NUMBER - 202331 / DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
AZILSARTAN KAMEDOXOMIL(UNII: WEC6I2K1FC) (AZILSARTAN - UNII:F9NUX55P23) | AZILSARTAN | 40mg | 40mg |
chlorthalidone(UNII: Q0MQD1073Q) (chlorthalidone - UNII:Q0MQD1073Q) | chlorthalidone | 25mg | 12.5mg |
Inactive Ingredients
Ingredient Name | Takeda Pharmaceuticals America, Inc. |
---|---|
alcohol(3K9958V90M) | |
butyl alcohol(8PJ61P6TS3) | |
cellulose, microcrystalline(OP1R32D61U) | |
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK) | |
ferric oxide red(1K09F3G675) | |
ferrosoferric oxide(XM0M87F357) | |
fumaric acid(88XHZ13131) | |
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |
hypromelloses(3NXW29V3WO) | |
magnesium stearate(70097M6I30) | |
mannitol(3OWL53L36A) | |
polyethylene glycol 8000(Q662QK8M3B) | |
shellac(46N107B71O) | |
sodium hydroxide(55X04QC32I) | |
talc(7SEV7J4R1U) | |
titanium dioxide(15FIX9V2JP) | |
water(059QF0KO0R) |
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